Just The News

GE Healthcare closes out field inspection of Millennium radiation therapy systems

13 hours ago

GE Healthcare (NYSE:GE) said last week that it closed out a full field inspection of all of its Millenium MG, MC and Myosight nuclear medicine systems after an incident in which the system malfunctioned. The company said that in September, it received notice that the top detector on on of its Millenium MG nuclear medicine systems detached […]

The post GE Healthcare closes out field inspection of Millennium radiation therapy systems appeared first on MassDevice.

Stealthy vascular play Efemoral Medical raises $1m

14 hours ago

Stealthy medtech startup Efemoral Medical has raised $1 million in a new round of equity financing, according to a recently posted SEC filing. TheLos Altos, Calif.-based company is reportedly focused n the vascular health market, and is “developing devices that restore flow in blood vessels without using potentially harmful permanent implants or resorting to limb […]

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TSO3 touts publication of Sterizone VP4 duodenoscope sterilization study

14 hours ago

TSO3 (TSE:TOS) yesterday touted the publication of results from a study exploring clinical in-use and simulated use testing of terminal sterilization of duodenoscopes with its Sterizone VP4 sterilizer. Results from the study were published in the American Journal of Infection Control, the Quebec City-based company said. Results from the study indicated that the Sterizone hydrogen peroxide-ozone […]

The post TSO3 touts publication of Sterizone VP4 duodenoscope sterilization study appeared first on MassDevice.

New Technique Allows for Live Retinal Cell Imaging

14 hours ago

Researchers at the National Eye Institute in the U.S. have developed a retinal imaging technique that reveals live neurons, blood vessels, and epithelial cells within the retina. The method involves combining adaptive optics and angiography, and allows the researchers to view complex units of cells that interact in the outer edge of the retina. As […]

Vapotherm closes $64m IPO

15 hours ago

Vapotherm said today it closed its initial public offering, raising a total $64.4 million in gross proceeds. The Exeter, N.H.-based company developed the Precision Flow line of devices to provide high-velocity heated, humidified and oxygenated air to treat patients with conditions such as pneumonia, chronic obstructive pulmonary disease, asthma and heart failure. Some 1,200 of […]

The post Vapotherm closes $64m IPO appeared first on MassDevice.

Nevro fires back in spinal cord stim patent spat with Boston Scientific

15 hours ago

Nevro (NYSE:NVRO) is seeking a reversal and remand for spinal cord stimulation patent infringement case against Boston Scientific (NYSE:BSX) that was ruled on this summer. A legal firm representing the company filed a brief this week seeking to overturn a decision from this summer which found a number of patent claims invalid as indefinite. In mid-July, a […]

The post Nevro fires back in spinal cord stim patent spat with Boston Scientific appeared first on MassDevice.

The Medtechy Daily: November 16, 2018

15 hours ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

FDA clears Thermi in “vaginal rejuvenation” product inquiry

17 hours ago

Temp-controlled radiofrequency tech developer Thermi said this week that the FDA granted it a notice of completion following an inquiry on products used in “vaginal rejuvenation” procedures. Irving, Texas-based Thermi received a notice from the FDA on July 24 regarding specific claims about the company’s ThermiVa device. The ThermiVa is a non-ablative RF device cleared […]

The post FDA clears Thermi in “vaginal rejuvenation” product inquiry appeared first on MassDevice.

EyeQue VisionCheck At-Home Eye Test for Self-Prescription of Glasses

17 hours ago

EyeQue, a company based in Newark, California, is releasing a vision testing system that you can use at home to test your eyes with the help of a smartphone. The EyeQue VisionCheck personal vision tracker snaps onto the screen of a smartphone and the user simply places it against the eye to perform the testing. […]

Boston Scientific Announces New Restructuring Program

17 hours ago

Boston Scientific posted an 8-K disclosing the approval of a new global restructuring plan meant to support the company's effort to improve operating performance and meet anticipated market demands.

GE divests $1.5B in healthcare equipment loan portfolio to TIAA Bank

17 hours ago

General Electric (NYSE:GE) has divested a portfolio of its healthcare equipment leases and loans from its GE Capital Healthcare Equipment Finance biz to TIAA Bank in a $1.5 billion deal as GE looks to trim down and narrow its focus, the companies said today. Jacksonville, Fla.-based TIAA Bank said today that the acquisition will expand its […]

The post GE divests $1.5B in healthcare equipment loan portfolio to TIAA Bank appeared first on MassDevice.

Medtronic touts 3-year Heli-FX EndoAnchor registry study data

18 hours ago

Medtronic (NYSE:MDT) today released three-year data from the Anchor registry study of its Heli-FX EndoAnchor system, touting that it indicated the system is safe, efficient and durable in treating patients with complex aortic abdominal aneurysm anatomy, specifically those with hostile aortic neck anatomies. Results from the trial were presented by co-principal investigator Dr. William Jordan of […]

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Edwards Lifesciences wins CE Mark for Sapien 3 Ultra TAVR

19 hours ago

Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Sapien 3 Ultra transcatheter aortic valve replacement system intended for patients with severe, symptomatic aortic stenosis. Despite winning a CE Mark, Edwards said that the new valve will not be launched in Germany due to a preliminary injunction from rival […]

The post Edwards Lifesciences wins CE Mark for Sapien 3 Ultra TAVR appeared first on MassDevice.

Valeritas prices $36m public offering

20 hours ago

Valeritas (NSDQ:VLRX) today priced an underwritten public offering of 75 million shares at 48¢ per share and accompanying warrants. The Bridgewater, N.J.-based company expects to reel in roughly $36 million in proceeds from the offering. Get the full story at our sister site, Drug Delivery Business News.

The post Valeritas prices $36m public offering appeared first on MassDevice.

Boston Scientific plans $200m restructuring

23 hours ago

Boston Scientific (NYSE:BSX) said yesterday that it’s planning a three-year restructuring program that’s slated to cost at least $200 million. The Marlborough, Mass.-based medical device maker said it expects to maintain roughly the same number of workers, although there will be some churn as new jobs are created. “[T]he company does expect some employee attrition and […]

The post Boston Scientific plans $200m restructuring appeared first on MassDevice.

AstraZeneca’s Mystic OS analysis paints tremelimumab as a dud in NSCLC

23 hours ago

Overall survival data from AstraZeneca’s phase 3 Mystic trial have cast more doubts on the prospects of anti-CTLA4 antibody tremelimumab. The readout suggests that, if anything, adding tremelimumab to PD-L1 drug Imfinzi results in worse outcomes in metastatic non-small cell lung cancer (NSCLC).

AstraZeneca’s Mystic OS analysis paints tremelimumab as a dud in NSCLC

23 hours ago

Overall survival data from AstraZeneca’s phase 3 Mystic trial have cast more doubts on the prospects of anti-CTLA4 antibody tremelimumab. The readout suggests that, if anything, adding tremelimumab to PD-L1 drug Imfinzi results in worse outcomes in metastatic non-small cell lung cancer (NSCLC).

The Medtechy Daily: November 15, 2018

1 day ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

SPR Therapeutics touts first CRPS treatment with Sprint PNS

2 days ago

SPR Therapeutics said today that it launched its FDA-cleared Sprint Endura single-lead peripheral nerve stimulation system intended for treating complex regional pain syndrome. Complex regional pain syndrome is a chronic pain condition affecting the limbs that can be caused by trauma, injury or surgery. The Cleveland-based company said that the device was used in its first […]

The post SPR Therapeutics touts first CRPS treatment with Sprint PNS appeared first on MassDevice.

Pulmonx wins Aetna coverage for Zephyr endobronchial valve

2 days ago

Pulmonx said yesterday that it won national coverage through health insurer Aetna for its Zephyr endobronchial valve system intended for treating severe emphysema and chronic obstructive pulmonary disorder. The coverage will make the Zephyr valve available to Aetna’s 22 million members, the Redwood City, Calif.-based company said. Under its new policy, Aetna specifically named the […]

The post Pulmonx wins Aetna coverage for Zephyr endobronchial valve appeared first on MassDevice.

Renal diagnostic dev RenalytixAI closes $29m IPO

2 days ago

AI-powered kidney disease and transplant management diagnostic developer RenalytixAI said this week it completed an $29 million initial public offering on the London Stock Exchange’s Alternative Investment Market. The company was formed through an exclusive license with Mount Sinai Health Systems, who also acted as a development collaborator. The groups have been collaborating since May […]

The post Renal diagnostic dev RenalytixAI closes $29m IPO appeared first on MassDevice.

MiMedx Whistleblower Speaks Out

2 days ago

Mike Fox, a client of Halunen Law, was a successful executive for MiMedx, a biopharmaceutical company that manufactures and sells regenerative and therapeutic biologics. Fox contends that his fortunes turned, however, when he challenged MiMedx and refused to participate in what he believed to be an illegal revenue recognition scheme.

HeartFlow wins Japanese reimbursement for FFRct analysis

2 days ago

HeartFlow said yesterday that it won reimbursement coverage from the Japanese Ministry of Health, Labor and Welfare for its HeartFlow FFRct fractional flow reserve analysis. The Redwood City, Calif.-based company said that it has already received approval from the Japanese Pharmaceuticals and Medical Devices Agency, and that reimbursement will go into effect beginning on December 1. […]

The post HeartFlow wins Japanese reimbursement for FFRct analysis appeared first on MassDevice.

L’Oréal Releases Sun Exposure Monitor Through Apple

2 days ago

L’Oréal, the big skin care company, has just released a tiny device for monitoring skin’s exposure to the sun. Offered through Apple’s online shop and at some of its physical stores, the La Roche-Posay My Skin Track UV device doesn’t use any batteries while being able to upload its readings to a paired smartphone. The energy of […]

Scientists Give Humans Ability to Sense Earth’s Magnetic Field

2 days ago

Birds and many other animals are able to perceive the Earth’s magnetic field, an ability that allows them to navigate around the world with magical ease. Scientists at Helmholtz-Zentrum Dresden-Rossendorf (HZDR), a research center in Dresden, Germany, have developed an electronic skin that can give humans the same capability. The new technology may end up being […]

Abbott wins CE Mark, FDA nod for DRG Invisible Trial neuromod system

2 days ago

Abbott (NYSE:ABT) said today that it won FDA clearance and CE Mark approval in the European Union for its DRG Invisible Trial System intended to allow patients with complex chronic pain conditions to receive a trial treatment with the company’s dorsal root ganglion stimulation system. Abbott’s DRG therapy targets the dorsal root ganglion, a structure adjacent to […]

The post Abbott wins CE Mark, FDA nod for DRG Invisible Trial neuromod system appeared first on MassDevice.

Combining Sound and Light Could Help with Early Ovarian Cancer Diagnosis

2 days ago

Researchers at Washington University in St. Louis have developed a diagnostic method involving photoacoustic imaging, a technique that combines ultrasound and laser light. The development may allow clinicians to diagnose ovarian cancer earlier, helping to save lives. “When ovarian cancer is detected at an early, localized stage – stage 1 or 2 – the five-year […]

Personalized Oxygen Releasing Insoles for Diabetic Foot Ulcers

2 days ago

Diabetic foot ulcers are common maladies that are difficult to heal. In many cases, a total-contact cast is put on the leg with the ulcer to take the pressure off of the bottom of the foot, helping it to heal. While this is effective, supplying oxygen to the ulcer also helps it to heal. This […]

Report: Smiths Group looks to spin off medical biz

2 days ago

Smiths Group (LON:SMIN) is looking to spin off its healthcare business and focus entirely on industrial tech after a failed $9.1 billion merger with ICU Medical (NSDQ:ICUI), according to a Reuters report. The company has considered a number of different options for the medical business, including a sale or separate listing, CEO Andy Reynolds said on a […]

The post Report: Smiths Group looks to spin off medical biz appeared first on MassDevice.

Bio-Rad, UChicago win $24m in patent infringement case

2 days ago

Bio-Rad Laboratories (NYSE:BIO) this week touted a joint legal victory with the University of Chicago in a US Federal District court against rival 10X Genomics, saying that it was awarded $23.9 million in damages in a patent infringement case. The jury in the trial unanimously found that 10X Genomics willfully infringed on Bio-Rad and Univ. of Chicago […]

The post Bio-Rad, UChicago win $24m in patent infringement case appeared first on MassDevice.

AbbVie's Orilissa makes its uterine fibroids case with double phase 3 win

2 days ago

AbbVie’s Orilissa snagged its first FDA approval over the summer, and now it’s looking to make it two. On Wednesday, the Illinois drugmaker unveiled details from a pair of phase 3 studies showing that the drug had topped placebo at reducing heavy menstrual bleeding related to uterine fibroids.

Chutes & Ladders—Dermavant hires Todd Zavodnick as CEO

2 days ago

Dermavant has hired Todd Zavodnick as CEO; Bayer VP Alan Westwood will lead antimicrobial firm Matoke Pharma; Genentech I-O leader Wei Lin will head up Nektar's oncology work; and Google is bringing on Geisinger’s CEO to direct its healthcare efforts. Those moves plus more hirings, firings and retirings throughout the industry.

Chutes & Ladders—Dermavant hires Todd Zavodnick as CEO

2 days ago

Dermavant has hired Todd Zavodnick as CEO; Bayer VP Alan Westwood will lead antimicrobial firm Matoke Pharma; Genentech I-O leader Wei Lin will head up Nektar's oncology work; and Google is bringing on Geisinger’s CEO to direct its healthcare efforts. Those moves plus more hirings, firings and retirings throughout the industry.

Canon Medical wins FDA nod for Vantage Orion 1.5T MRI

2 days ago

Canon (NYSE:CAJ) Medical Systems said today that it won FDA 510(k) clearance for its Vantage Orian 1.5 Tesla magnetic resonance imaging system. The Japan-based company said that the clearance of the Vantage Orian “represents a new standard in the premium wide bore 1.5T market,” and touted that the device includes new technology intended to improve productivity, patient […]

The post Canon Medical wins FDA nod for Vantage Orion 1.5T MRI appeared first on MassDevice.

Dartmouth-Hitchcock hospitals to deploy Philips’ tele-ICU program

2 days ago

Dartmouth-Hitchcock Health (Lebanon, N.H.) has agreed to implement Royal Philips’ (NYSE: PHG) eICU program technology.  The program aims to help reduce mortality, length of stay, and ventilation days while providing care to patients wherever they are located. Philips’ eICU is a tele-ICU program that will link specialists at the health system’s flagship hospital, Dartmouth-Hitchcock Medical Center […]

The post Dartmouth-Hitchcock hospitals to deploy Philips’ tele-ICU program appeared first on MassDevice.

Lyndra touts positive results for long-acting drug-delivery tech

2 days ago

Lyndra Therapeutics reported positive results from a pharmacokinetics study of its once-weekly drug-delivery capsule, touting that it successfully transitioned a once-daily therapy to a weekly dosage form. The Watertown, Mass.-based company’s oral drug-delivery technique is designed to provide sustained release of one or more drugs for up to a week. Lyndra’s star-shaped capsule opens when it […]

The post Lyndra touts positive results for long-acting drug-delivery tech appeared first on MassDevice.

Abbott warns against below-market mini-tender offer

2 days ago

Abbott (NYSE:ABT) yesterday released a notice warning against an unsolicited mini-tender offer by Baker Mills looking to purchase 60,000 shares of Abbott’s stock at $57 per share, lower than the company’s current share price. The tender offer price is 17.9% below Abbott’s closing price yesterday of $69.41, and 22% lower than the company’s $72.79 closing price […]

The post Abbott warns against below-market mini-tender offer appeared first on MassDevice.

ivWatch inks distro deal for IV monitoring device

2 days ago

ivWatch said this week that it landed an international partner to manage the distribution of its continuous intravenous monitoring device. The Hampton, Va.-based company inked a deal with supplier New Medical to distribute its ivWatch Model 400 system in Australia and New Zealand. Get the full story at our sister site, Drug Delivery Business News.

The post ivWatch inks distro deal for IV monitoring device appeared first on MassDevice.

Dermavant hires Todd Zavodnick as CEO 

2 days ago

Dermavant has named Todd Zavodnick as its CEO. The dermatology-focused Roivant subsidiary hired Zavodnick to fill a leadership space vacated by Jackie Fouse in September.

Dermavant hires Todd Zavodnick as CEO 

2 days ago

Dermavant has named Todd Zavodnick as its CEO. The dermatology-focused Roivant subsidiary hired Zavodnick to fill a leadership space vacated by Jackie Fouse in September.

UniQure’s hemophilia B gene therapy achieves 31% FIX activity

2 days ago

UniQure has posted eagerly anticipated data on the modified hemophilia B gene therapy it plans to take into phase 3. The FIX-Padua variant therapy achieved factor IX (FIX) activity levels of 23% to 37%, suggesting it is several times more effective than the version uniQure tested in earlier-phase trials.

UniQure’s hemophilia B gene therapy achieves 31% FIX activity

2 days ago

UniQure has posted eagerly anticipated data on the modified hemophilia B gene therapy it plans to take into phase 3. The FIX-Padua variant therapy achieved factor IX (FIX) activity levels of 23% to 37%, suggesting it is several times more effective than the version uniQure tested in earlier-phase trials.

Artificial Intelligence Diagnoses Heart Murmurs Better Than Expert Cardiologists

3 days ago

At the just concluded American Heart Association’s Scientific Sessions 2018 in Chicago, Eko, the makers of popular digital stethoscopes, showed off a neural network AI algorithm that is able to detect murmurs better than a group of cardiologists. The study, titled “Artificial Intelligence Detects Pediatric Heart Murmurs With Cardiologist-Level Accuracy,” involved teaching a computer to spot […]

AliveCor's Next App Could Save You From a Heart Attack

3 days ago

Alivecor, maker of ECG software and hardware for the iPhone and other mobile devices, received another impressive victory this week as an international study found that their smartphone app was nearly as accurate as a 12-lead ECG in determining if a patient is having an ST-segment elevation myocardial infarction (STEMI).

FDA Clears Canon’s Vantage Orian 1.5 Tesla MRI

3 days ago

Canon Medical won FDA clearance to bring to the U.S. market its brand new Vantage Orian 1.5 Tesla MRI scanner. It features a wide 71 centimeter bore and quiet operation thanks to its Pianissimo and Pianissimo Zen technologies. Pianissimo makes all scanning sequences quieter, while Pianissimo Zen allows certain scans to be performed at near […]

Mental Illness Body Tracker Accurately Diagnoses PTSD

3 days ago

Mental illness can be notoriously difficult to diagnose in many cases, since symptoms may be invisible to physicians and those that are can be misleading. Objective methods that don’t rely on a direct observation would help to improve diagnosis. Researchers at Draper, the famous engineering firm in Cambridge, Massachusetts, have developed a system consisting of […]

Reminder: Medgadget 2018 Sci-Fi Writing Contest: Win The Eko Digital Stethoscope

3 days ago

It’s that time of the year when we call on technological visionaries, medical futurists, and creative people of all kinds to submit medical science fiction stories to our annual Medgadget Sci-Fi Writing Contest. At Medgadget, we keep a record of the progress of medical technologies and hope to inspire you to imagine a future where medicine is able to […]

Eli Lilly files for FDA approval of migraine drug lasmiditan

3 days ago

Eli Lilly has filed for FDA approval of migraine drug lasmiditan. The Big Pharma is seeking approval of the 5-HT1F agonist on the strength of late-phase data showing the drug clears headache pain in two hours in some patients.

Eli Lilly files for FDA approval of migraine drug lasmiditan

3 days ago

Eli Lilly has filed for FDA approval of migraine drug lasmiditan. The Big Pharma is seeking approval of the 5-HT1F agonist on the strength of late-phase data showing the drug clears headache pain in two hours in some patients.

Preclinical biotech Synthorx wants a $100M IPO

3 days ago

Moderna will be getting all the headlines for its monster $500 million IPO attempt this week, but that shouldn’t overshadow the major $100 million IPO that early-stage Synthorx has just announced, and what this says about the biotech market.

Preclinical biotech Synthorx wants a $100M IPO

3 days ago

Moderna will be getting all the headlines for its monster $500 million IPO attempt this week, but that shouldn’t overshadow the major $100 million IPO that early-stage Synthorx has just announced, and what this says about the biotech market.

The Medtechy Daily: November 13

4 days ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

Abiomed's Impella Pilot Trial to Treat Heart Attack Patients Is Successful, Moves on to Pivotal Trial

4 days ago

Abiomed (NASDAQ: ABMD) announces the results of the FDA STEMI Door-to-Unloading safety and feasibility randomized controlled trial, which show unloading the left ventricle with Impella CP for 30 minutes prior to reperfusion in patients presenting with anterior ST-segment elevation myocardial infarction (STEMI) without cardiogenic shock is safe and feasible, when compared to Impella patients reperfused immediately.

GSK pancreatic cancer drug heads to phase 1 combo with Merck's Keytruda after positive mouse trial

5 days ago

GlaxoSmithKline’s experimental drug GSK095, a RIP1 inhibitor, is designed to work in tandem with checkpoint-inhibiting medicines in the hopes of empowering the immune system to launch a more aggressive attack against tumors than it does with checkpoint inhibitors alone. Early results from a trial of a related GSK drug suggest that combining the drug with Merck's blockbuster Keytruda holds promise in treating pancreatic cancer.

GSK pancreatic cancer drug heads to phase 1 combo with Merck's Keytruda after positive mouse trial

5 days ago

GlaxoSmithKline’s experimental drug GSK095, a RIP1 inhibitor, is designed to work in tandem with checkpoint-inhibiting medicines in the hopes of empowering the immune system to launch a more aggressive attack against tumors than it does with checkpoint inhibitors alone. Early results from a trial of a related GSK drug suggest that combining the drug with Merck's blockbuster Keytruda holds promise in treating pancreatic cancer.

The Medtechy Daily: November 9

1 week ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

RTI Surgical Acquires Paradigm Spine

1 week ago

In early November, RTI Surgical ($RTIX) announced that they entered an agreement to acquire Paradigm Spine in a deal worth up to $300 million.

The Medtechy Daily: November 6

2 weeks ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

Nevro Revenue Growth Slows in the Third Quarter

2 weeks ago

Nevro ($NVRO) shares were down 14% in early morning trading as the company reported third quarter earnings, bringing in revenue of $95.6 million versus $82.3 million during the third quarter of 2017, resulting in 16% year-over- year growth.

The Medtechy Daily: November 5

2 weeks ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

The Medtechy Daily: November 2

2 weeks ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

Botox Drives Allergan Earnings

2 weeks ago

While overall revenue decreased, there were continued bright spots by Allergan's key promoted brands which represented nearly 90 percent of total revenues, growing 5.9 percent versus prior year.

The Medtechy Daily: October 31

2 weeks ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

The Medtechy Daily: October 30

3 weeks ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

The Medtechy Daily: October 29

3 weeks ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

Tesla to offer employees 'first-class' health clinics

3 weeks ago

More companies are moving towards offering employees on-site healthcare options as Elon Musk announced during Tesla's earnings call yesterday that the company recently opened a new and improved health clinic for employees.

The Medtechy Daily: October 24

3 weeks ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

Intuitive Surgical's Commitment to Innovation Can't be Overlooked

4 weeks ago

The future of robotic surgery is bright. With major players like Medtronic and Johnson & Johnson reportedly coming to market, and smaller players like TransEnterix already on the market, surgeon customers will have more options than they have had in the past.

The Medtechy Daily: October 22

4 weeks ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

The Medtechy Daily: October 18

4 weeks ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

The Medtechy Daily: October 15

1 month ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

The Medtechy Daily: October 12

1 month ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

The Medtechy Daily: October 11

1 month ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

The Medtechy Daily: October 10

1 month ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

The Medtechy Daily: October 9

1 month ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

The Medtechy Daily: October 8

1 month ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

Bose hearing aid gets FDA approval

1 month ago

The FDA recently cleared a new device, the Bose Hearing Aid, which was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.

The Medtechy Daily: October 5

1 month ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

The Medtechy Daily: October 4

1 month ago

The Medtechy Daily provides the latest news and insight for the medical technology industry, including medical device, biotech and digital health.

Endologix Announces Preliminary Earnings, Raises Outlook

1 month ago

Endologix, Inc. ($ELGX), soared in early trading as the company announced preliminary unaudited revenue for the third quarter ended September 30, 2018 is expected to be in the range of $34.3 million to $34.7 million.

TransEnterix 2018 Key Priorities Still on Track

1 month ago

Writing about TransEnterix ($TRXC) has been fun in the past year as the company has consistently executed on the key priorities that CEO Todd Pope has laid out. As mentioned in our TransEnterix SWOT analysis after their most recent earnings call, the fourth quarter would be "the tell" when it comes to understanding overall business health and growth of TransEnterix.

Stryker Acquires HyperBranch Medical for $220 Million

2 months ago

Stryker ($SYK) continued their acquisition spree today as they announced the acquisition of privately-held HyperBranch Medical Technology, Inc. for a total equity value of approximately $220 million in an all cash transaction.

Medical Device Industry New Victim of Trump's Trade War

2 months ago

According to a report from Forbes, the medical device industry is expecting to be significantly impacted by Donald Trump’s trade war with China as nearly $5 billion in U.S. medical devices are now impacted from retaliatory Chinese tariffs.

Boston Scientific Launches LithoVue Empower Retrieval Deployment Device

2 months ago

Boston Scientific announced the global launch of the LithoVue Empower Retrieval Deployment Device, designed to be used with the LithoVue Single-Use Digital Flexible Ureteroscope and compatible nitinol retrieval basket to enable urologists to operate a ureteroscope and basket simultaneously when retrieving kidney stones via flexible ureteroscopy (URS).

SI-BONE Files for IPO

2 months ago

Santa Clara based, SI-BONE, developer of the minimally invasive surgical treatment of the sacroiliac joint with the iFuse Implant System, filed a registration statement on Form S-1 with the SEC relating to a proposed initial public offering of shares of its common stock.

Free Job Postings on Medtechy Jobs Until 2019

2 months ago

In an effort to provide the most valuable experience for job seekers and the companies and recruiters providing opportunities on Medtechy Jobs, we have decided to offer free job postings through the remainder of 2018.

Stryker Acquires Invuity for $7.40/Share

2 months ago

Stryker has entered into a definitive agreement to acquire all the issued and outstanding shares of Invuity for $7.40 per share, or a total equity value of approximately $190 million.

FDA Launches Quik Review Pilot Program for Certain Medical Devices

2 months ago

FDA commissioner, Scott Gottlieb, announced that the FDA will launch the Quality in 510(k) (“Quik”) Review Program Pilot for certain moderate-risk medical devices as part of the agency’s ongoing efforts to improve the efficiency and consistency of the premarket notification 510(k) review process.

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