FDA moving ahead with rulemaking on lab developed tests without waiting for Congress: BioWorld

A senior FDA official said the agency cannot “just stand by” given the failure of Congress to pass legislation addressing regulation of the increasingly complex tests.

By Nick Paul Taylor • March 2, 2023

Remote patient monitoring increasingly popular, even as pandemic eases, analysis of insurance claims shows

Cardiologists are the main users of RPM devices, with blood pressure diagnoses accounting for more than half of all claims made in 2021. Diabetes, which accounts for 16% of claims, is the next most active area.

By Nick Paul Taylor • March 2, 2023

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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

AdvaMed unveils policy priorities with focus on breakthrough device coverage, global market access

Congress should also prioritize protecting the medtech manufacturing supply chain and enact diagnostic testing reform, the lobbying group said in releasing a set of nine policy goals.

By Susan Kelly • March 1, 2023

FDA authorizes first at-home flu-COVID-19 combination test days after its developer files for bankruptcy

Lucira filed for bankruptcy protection last week, saying the “protracted” authorization process caused it to miss out on test sales in the 2022 to 2023 flu season.

By Nick Paul Taylor • Feb. 27, 2023

Getinge has CE marks suspended on life support sets over sterile packaging issues

Getinge said it is “aware of the severe situation this suspension puts on healthcare and critically ill patients” and is “working urgently to minimize the impact.”

By Nick Paul Taylor • Feb. 24, 2023

Biden upholds finding that Apple Watch violated AliveCor’s patents

A ban on the infringing Apple Watches could be enacted under a ruling by the International Trade Commission, but a separate patent case must be resolved first.

By Elise Reuter • Feb. 21, 2023

Device makers gain more time to adapt to Europe’s MDR after EU vote

The European Parliament’s approval means that medtech manufacturers have until 2027 or 2028 to comply with the new rules, depending on device class.

By Susan Kelly • Feb. 17, 2023

GE’s nuclear imaging device can crush patients, FDA says, as Class I recall issued

GE HealthCare has told customers to stop using the machines until company technicians can inspect them and replace dangerous parts. 

By Nick Paul Taylor • Feb. 17, 2023

AI devices need dedicated FDA regulatory pathway to reduce bias risk, say researchers

Scientists argue for a new regulatory process to prevent AI software from reinforcing existing health disparities.

By Nick Paul Taylor • Feb. 16, 2023

Boston Scientific, MDMA call for more transparency and oversight of Medicare Advantage plans

Privately offered Medicare Advantage plans “do not often provide a clear reason for the denial of coverage, and rarely offer any visibility into the evidence and methodology,” trade group MDMA and Boston Scientific said. 

By Nick Paul Taylor • Feb. 15, 2023

Patent trolls’ destructive lawsuits are curbing US medtech innovation

The Patent and Trademark Office must help stop frivolous litigation that is harming the industry, argues former HHS secretary Tom Price.

By Tom Price • Feb. 10, 2023

82 more deaths linked to Philips’ recalled devices reported to FDA, bringing total to 346

The rate of death reports per month has risen consistently since Philips began the recall in the summer of 2021.

By Nick Paul Taylor • Feb. 10, 2023

Abbott balloon device partner Surmodics cuts jobs after FDA approval delay

The workforce reduction, one of a growing number in the medtech sector, comes after the agency requested more data in a premarket review of the company’s device to treat narrowed leg arteries.

By Susan Kelly • Feb. 9, 2023

Biden zeroes in on drug costs during State of the Union address

The president called for extending Medicare's $35 insulin price cap to all Americans and blasted “big pharma” for record profits while at the same time “unfairly charging people hundreds of dollars.”

By Shannon Muchmore • Feb. 8, 2023

Trade group pushes back on FDA’s clinical decision support guidance

The Clinical Decision Support Coalition is asking the agency to rescind its guidance and propose new rules that change how software tools are regulated as medical devices. 

By Elise Reuter • Feb. 8, 2023

UK health system, under strain, lays out medtech strategy

The state-run National Health Service, now facing a strike by nurses and paramedics, hopes new technologies will help solve some of its long-term challenges to improve patient care.

By Susan Kelly • Feb. 7, 2023

FTC orders GoodRx to stop sharing users’ health data with advertisers, issues $1.5M fine

Regulators said they are putting the industry on watch with the enforcement against GoodRx, which allegedly collected data, including patient medications, and shared it without user consent.

By Rebecca Pifer • Updated Feb. 1, 2023

FDA device center’s 2022 report reveals 37% drop in annual breakthrough designations

The annual report also highlighted the CDRH’s work on pulse oximeters, Philips’ recall of sleep and respiratory devices, cybersecurity and artificial intelligence.

By Nick Paul Taylor • Jan. 31, 2023

Philips will cut 6,000 more jobs to reduce costs after company swung to net loss in Q4

New CEO Roy Jakobs said Philips has been spreading its resources too thinly and “can't and won't be selling everything everywhere anymore.”

By Nick Paul Taylor • Jan. 30, 2023

Medtech regulation outlook in 2023: Faster approvals among priorities as AI moves to fore

Leaders in the medtech field weigh in on the prospects and challenges for product regulation in 2023.

By Peter Green • Updated Jan. 26, 2023

Getinge heart pump gets third Class I recall after patient death

Customers were alerted to problems with Cardiosave devices late last year after Getinge received complaints about an issue linked to four serious injuries and one death.

By Nick Paul Taylor • Jan. 26, 2023

Insulet reports personal-data leak of 29,000 insulin pump customers

In a recall communication to users, Insulet shared information with its website performance and marketing partners through cookies and other trackers embedded in its website. 

By Nick Paul Taylor • Jan. 24, 2023

Ethylene oxide regulation may disrupt device supply, AdvaMed warns White House

The trade group has asked President Joe Biden to consider the potential threat to patient care if facilities are shut down.

By Nick Paul Taylor • Jan. 23, 2023

FDA demands additional data on Abbott rival to Medtronic balloon, setting back approval timeline

Abbott’s partner Surmodics is “evaluating options” to reduce its spending while preparing a response to the regulator’s requests.

By Nick Paul Taylor • Jan. 20, 2023

Medtech hazards: Problems with Philips’ recall put safety of home-use devices at top of danger list

Patient safety group ECRI is challenging manufacturers to provide easy-to-follow device registration instructions and write simply worded recall notices.

By Nick Paul Taylor • Jan. 19, 2023