FDA finalizes Voluntary Malfunction Summary Reporting guidance

The agency clarified when companies can submit device malfunction reports in a quarterly summary, instead of individual reports every 30 days.

By Nick Paul Taylor • Aug. 30, 2024

Medtronic’s chief medical officer of acute care and monitoring departs for new role

Sam Ajizian leaves Medtronic six months after the company reversed a plan to split off its patient monitoring business.

By Nick Paul Taylor • Aug. 30, 2024

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Penumbra axes virtual reality division, will lay off 71 people

CEO Adam Elsesser told investors the company’s focus needs to be on its core thrombectomy business as it cut its sales forecast for 2024.

By Elise Reuter • Aug. 29, 2024

Johns Hopkins, CareFirst, Techstars launch healthcare AI accelerator

The 13-week program will offer funding and guidance to up to 12 health tech, medtech and biotech startups working on AI tools.

By Emily Olsen • Aug. 29, 2024

Boston Scientific receives CE mark for updated TAVR technology

Changes include the addition of a larger valve size that company executives have said will open up 25% of the market in Europe.

By Nick Paul Taylor • Aug. 28, 2024

UFP to buy device component maker AQF Medical, extending deal spree

AQF makes foam and thermoplastic components for use in medical devices and packaging.

By Nick Paul Taylor • Aug. 28, 2024

Insulet’s Trang Ly on overcoming ‘clinical inertia’ in diabetes care

Automated insulin delivery for Type 2 patients can help change minds among physicians who have been reluctant to prescribe pump therapy, the chief medical officer said in an interview.

By Susan Kelly • Aug. 27, 2024

Inari updates label of clot removal device linked to 6 deaths

Inari recalled the catheter and revised instructions for use after reports of the device becoming entrapped or blocking patients’ lung arteries.

By Nick Paul Taylor • Aug. 27, 2024

Siemens Healthineers to grow PET imaging with purchase of Novartis assets

Siemens will pay 200 million euros for the manufacturing and distribution network of Novartis’ radiopharmaceutical molecular imaging business.

By Nick Paul Taylor • Aug. 27, 2024

Insulet expands Omnipod 5 pump to people with Type 2 diabetes

The FDA clearance marks the first automated insulin delivery system for people with Type 2 diabetes.

By Elise Reuter • Aug. 26, 2024

Dexcom prices first over-the-counter glucose monitor

Known as Stelo, the device is intended for people who don’t take insulin and costs $89 per month.

By Elise Reuter • Aug. 26, 2024

FDA seeks feedback on predetermined change control plans

The guidance describes changes companies can make to medical devices without filing a new 510(k) or premarket approval supplement.

By Nick Paul Taylor • Aug. 26, 2024

Defibtech recalls chest compression device linked to patient death

Customers are asked to return affected devices due to a problem in the motor that could stop compressions.

By Nick Paul Taylor • Aug. 26, 2024

Stryker to add back pain treatment with Vertos Medical buy

Stryker’s latest purchase comes amid a pickup in medtech M&A, with Johnson & Johnson, Boston Scientific and Edwards Lifesciences all active this year.

By Susan Kelly • Aug. 23, 2024

Procept wins FDA clearance for updated prostate surgery robot

Procept Biorobotics has added AI capabilities and switched to a single-use scope to support mass-market adoption.

By Nick Paul Taylor • Aug. 22, 2024

Zoll to buy Vyaire’s ventilator business with $37M auction bid

Vyaire Medical held a virtual auction of assets after filing for Chapter 11 bankruptcy protection in June.

By Nick Paul Taylor • Aug. 21, 2024

FDA’s plan to expand device surveillance faces challenges, GAO finds

Funding issues and limited use of unique device identifiers are hurdles to expanding an FDA system to monitor medical device safety, the federal watchdog said.

By Nick Paul Taylor • Aug. 21, 2024

Masimo’s consumer audio brands attract more suitors

Negotiations with a potential joint venture partner will continue while Masimo initiates discussions with new parties that have expressed interest in the consumer audio business.

By Susan Kelly • Aug. 21, 2024

J&J to buy heart failure implant maker V-Wave for up to $1.7B

J&J has agreed to pay $600 million upfront for the private company as it works to expand its portfolio of cardiovascular devices.

By Susan Kelly • Aug. 20, 2024

Edwards continues M&A spree with Genesis’ TAVR tech

Edwards, which has made a series of acquisitions in recent months, is also investing $25 million in Singapore-based Genesis Medtech.

By Susan Kelly • Aug. 19, 2024

Histosonics raises $102M for noninvasive treatment to destroy tumors

Using sound waves to break down tumor tissue can offer patients with liver cancer an alternative to surgery, radiation and chemotherapy.

By Susan Kelly • Aug. 19, 2024

Biden pledges $150M for medical tech to improve cancer surgery

Awards include funding for microscopy and imaging tools to help surgeons ensure all cancer is removed during a procedure.

By Elise Reuter • Aug. 16, 2024

Stereotaxis earns CE mark for new surgical robot

CEO David Fischel said the platform, called GenesisX, is designed to address challenges hospitals have faced when installing the company’s earlier robotic systems.

By Susan Kelly • Aug. 15, 2024

Tandem warns iPhone app still draining insulin pump batteries

Despite a software update in March, users are still reporting that the app is rapidly depleting their insulin pump batteries, causing unexpected shutdowns.

By Elise Reuter • Aug. 15, 2024

Neuronetics inks Greenbrook merger to acquire treatment centers

William Blair analysts said the deal changes Neuronetics’ profile “from device-centric to a device-service business operating brick-and-mortar facilities.” 

By Nick Paul Taylor • Aug. 15, 2024