Edwards head of TAVR, Larry Wood, says more urgency needed in treating heart valve disease

Continued staffing shortages at hospitals are delaying the non-invasive aortic valve procedures for patients in need. 

By Elise Reuter • Sept. 16, 2022

Baxter’s recall of solution sets used in chemotherapy labeled Class I by FDA amid complaints of leaks

The regulator says the leaks could kill, but with 83 complaints it has not received reports of patient injuries or deaths.

By Ricky Zipp • Sept. 15, 2022

Explore the Trendline➔

Medical device safety in spotlight after high profile recalls

From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

By MedTech Dive staff

Tasso’s at-home blood collection lancet wins FDA clearance

Tasso is pitching the device as an enabler of decentralized clinical trials because it could simplify the collection of blood at home.

By Nick Paul Taylor • Sept. 15, 2022

FBI warns of cyber risks from legacy medical devices

Outdated device software can put data, patient safety and hospitals’ operations at risk, the top U.S. law enforcement agency warned.

By Ricky Zipp • Sept. 15, 2022

Medtech firms increasingly positive about future as staffing, inflation pressures ease, say RBC analysts

Hospital staffing and supply chain issues are expected to improve, according to comments from Boston Scientific, J&J, Medtronic, and others.

By Nick Paul Taylor • Sept. 15, 2022

Medtronic reports two deaths related to endotracheal tube recall

The company also received reports of three injuries related to airway obstruction with the tubes, adding to the company’s recent recall woes.

By Elise Reuter • Updated Sept. 14, 2022

Edwards updates Sapien TAVR device for greater durability

The device uses Edwards’ Resilia tissue technology to enable dry storage and potentially extend device durability.

By Nick Paul Taylor • Sept. 14, 2022

Sony partners with hearing aid specialist to enter new over-the-counter market

Sony has identified the U.S. regulatory change as a chance to use its brand and audio technology to add a new growth driver to its portfolio.

By Nick Paul Taylor • Sept. 14, 2022

Investor lawsuit accuses Medtronic of failing to disclose insulin pump problems

The plaintiffs claim Medtronic failed to disclose that its product quality control systems were inadequate and that it was noncompliant with regulations.

By Nick Paul Taylor • Sept. 13, 2022

J&J agrees to settle class action pelvic mesh suits in Australia for more than $200M

Shine Lawyers, the firm representing the patients, said that the Federal Court of Australia still needs to approve the terms of the agreement.

By Ricky Zipp • Sept. 13, 2022

Catheter Precision agrees to reverse merger, securing cash to target cardiac electrophysiology market

By merging into Ra Medical Systems, Catheter Precision has access to public markets and a pool of cash needed to bring its product to market.

By Nick Paul Taylor • Sept. 13, 2022

Medtronic signs development deal with surgical robot-maker Titan Medical

Medtronic placed a $2.6 million order for some of the company’s instruments and cameras, and its interest in Titan should help the smaller firm as it seeks to win approval for its device and market it globally.

By Elise Reuter • Sept. 12, 2022

Philips says French prosecutors investigating respirator recall

While the company confirmed it faces lawsuits in France, Philips said it’s too early “to speculate about any potential exposure.”

By Elise Reuter • Sept. 9, 2022

FDA alerts physicians to lock malfunction with Abbott’s MitraClip heart valve device

The problem, which the FDA said occurs in 1.3% of procedures, can have consequences including the need for surgery to treat significant residual disease. 

By Nick Paul Taylor • Sept. 9, 2022

FDA: Reports of squamous cell carcinoma, lymphomas in scar tissue around breast implants

The report adds to the history of product safety problems for breast implant devices, including patient injuries and deaths.

By Ricky Zipp • Sept. 8, 2022

Cybersecurity firm finds vulnerabilities in Baxter’s Sigma infusion pumps

The weaknesses could allow attackers to access Wi-Fi data and make the device unavailable.

By Nick Paul Taylor • Updated Sept. 8, 2022

French prosecutors investigating Philips Respironics recall: Reuters

In addition to a U.S. DOJ inquiry, Philips now faces an investigation from French prosecutors over its recall of sleep apnea machines and ventilators. 

By Elise Reuter • Sept. 8, 2022

Abbott heart device for newborns shows longer-term benefits with three-year data

The trial results give Abbott more evidence as it seeks to position the product as an alternative to medical management or surgical ligation.

By Nick Paul Taylor • Sept. 8, 2022

FDA clears Magnus neuromodulation system in major depressive disorder

Almost 80% of people treated with the SAINT system entered remission, compared to 13% of their peers in the control group.

By Nick Paul Taylor • Sept. 7, 2022

Philips recalls 17M sleep apnea masks over magnets that could affect implanted devices

The problem has caused 14 serious injuries, and the FDA cautioned that the issue could lead to deaths.

By Nick Paul Taylor • Updated Sept. 8, 2022

European Commission blocks Illumina-Grail deal to ‘preserve competition’ in cancer test market

The EC decision comes after a U.S. ruling to let the acquisition move forward and leaves Illumina facing an uncertain future in a competitive market for next-generation gene tests to detect cancer.

By Ricky Zipp • Sept. 6, 2022

Medtronic recalls endotracheal tubes after reports of airway obstruction

The recall includes certain brands of Medtronic’s EMG endotracheal tubes and affects more than 600,000 devices worldwide.

By Elise Reuter • Sept. 2, 2022

Friday Q&A: iRhythm CTO Mark Day talks Zio Watch, Verily partnership, Big Tech in healthcare

Day spoke about developing a smartwatch for cardiac monitoring with Alphabet’s Verily, competing with Apple and building clinical evidence for the new product.

By Ricky Zipp • Sept. 2, 2022

Vibrating, colon-stimulating capsule to treat chronic constipation approved by FDA

Vibrant Gastro’s drug-free capsule increased complete spontaneous bowel movements in a pivotal clinical trial, opening a new treatment pathway for the millions of Americans suffering from severe constipation.

By Nick Paul Taylor • Sept. 2, 2022

Philips pays $24M to settle second set of claims by US Justice Dept.

Respironics allegedly purchased, “at a significant cost to itself,” data on the prescribing decisions of U.S. physicians and gave the information to durable medical equipment suppliers so that they would promote its products.

By Nick Paul Taylor • Sept. 2, 2022