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AdvaMed, state AGs weigh in ahead of EPA sterilization rule

About a year after FDA told the medical device industry the closure of an Illinois ethylene oxide facility could disrupt supply chains, environmental regulators are considering changes that could affect sterilizers across the country.

Dexcom hopes wave of new customers offsets lower prices, Abbott's sweet spot

The continuous glucose monitor maker also said it's planning a third manufacturing site, this time outside of the U.S., as it prepares for demand beyond its mainstay Type 1 diabetes market.

Medtronic buys British surgical AI company, adding to Hugo robot effort

The acquisition of Digital Surgery comes as Medtronic inches its own soft tissue robot toward competition with Intuitive's da Vinci.

Baxter overstated income by $278M, internal probe finds

The fallout may drag on from Baxter's use of a flawed method to calculate exchange rates over several years. The medtech continues to work with the SEC and potential investor class action lawsuits could follow.

Insulet warns of defect with Dash personal diabetes manager

The notice came a day after FDA flagged a potential safety issue with certain Medtronic insulin pumps. Although the source of risk was different, the possible outcome was the same: under or over delivery of insulin.

Moody's: Coronavirus spread in US to have mixed credit effects across healthcare

Device makers — particularly Boston Scientific, BD and Abbott — will likely see a credit negative effect from supply chain disruption, even if the outbreak is contained to China.

EU MDR notified bodies hit 11 with Irish group added

The National Standards Authority of Ireland describes itself as the country's official standards body. It's the second certified since the Commission teased last month that three more of the entities would soon be added to the count.

UPDATED: Feb. 13, 2020 at 11:01 a.m.

LabCorp weathers rising personnel costs to beat expectations in Q4

Quest Diagnostics said the trend is an emerging source of pressure, while LabCorp had a more tempered reaction.

FDA folds Cook Medical asks into final peripheral vascular atherectomy device 510(k) guidance

The agency made some changes to advice on premarket submissions for technologies used to help remove plaque from diseased arteries.

Emergency use coronavirus tests shows glitches at state level, CDC says

CDC officials said Wednesday that some of the test kits it distributed to states produced inconclusive results when tested independently. The agency noted the tests were not run on patients.

UPDATED: Feb. 13, 2020 at 11:20 a.m.

Medtronic insulin pump recall tied to 1 death, more than 2K injuries, FDA says

A hardware issue the medtech giant flagged to certain MiniMed customers in November has generated more than 26,000 complaints, the agency said as it classified the recall in its highest-risk category.

Exact Sciences beefs up sales force as it seeks big Cologuard growth in 2020

The cancer diagnostics company said fresh TV ads and physicians' increasing ability to place orders through an updated version of Epic will spur sales of its colorectal cancer test.

FDA OKs 'Inside-Out' device for enabling hemodialysis in hard-to-treat patients

Bluegrass Vascular Technologies plans to make its De Novo-winning venous access device available at select U.S. sites in the coming months, adding to the revenue it already generates in the EU, Canada and other markets.

Tenet to pay $1.4M to settle claims it unnecessarily implanted cardiac monitors

The unneeded procedures subjected patients to "needless peril, and taxpayers end up with the bill," said an HHS Office of Inspector General special agent.

Wearable heart rate sensor accuracy didn't vary across skin tones in small Duke study

But data from 53 individuals, published Monday, revealed differences in accuracy by device manufacturer across activity type.

Intuitive buys IT startup for surgical video sharing, archiving, analysis

The acquisition of clinical video and image documentation company Orpheus Medical comes as big players like J&J and Medtronic are preparing to shake up the robotic surgery market. 

Renewed calls for Impella RCT as JAMA details bleeding, death rate findings

Abiomed has cast doubt on the registry-based study, though some cardiologists argue it supports “a more restrictive use” of the circulatory support device.

Hospitals, clinics most likely to be hit with ransomware attack

But medical testing and supplies companies weren't spared among the 172 individual attacks from 2016 to 2019 that affected 6.6 million patients. 

Medtronic faces key test in establishing US market for renal denervation

After a setback six years ago, the medtech giant is set to unveil pivotal trial data next month on a procedure to lower blood pressure. Abbott and Boston Scientific are likely watching closely.

FDA OKs 1st AI tool to help non-specialists take cardiac ultrasounds

The De Novo authorization comes weeks before the agency will host a meeting on artificial intelligence in radiological imaging.

FDA puts high-risk label on GE Healthcare anesthesia systems recall

A potential loose cable connection in more than 3,600 of the devices may result in a loss of mechanical ventilation.

Longtime Myriad CEO resigns amid another steep earnings miss, guidance cut

Sales in the prenatal and hereditary cancer divisions, plus the seemingly promising GeneSight line, all declined during the quarter.

BD cuts 2020 guidance on Alaris pump hangup with FDA, stock tanks

"Resetting expectations is certainly not how I want to start my first call as CEO," new BD head Tom Polen told analysts. Shares were down as much as 13% Thursday morning.

VA facility claimed as 'world's 1st' 5G-enabled hospital

The Palo Alto Health Care System's 5G infrastructure — the fifth generation of cellular mobile communications — will be operational this week, VA Secretary Robert Wilkie said Wednesday.

Abiomed, on defense, plans wave of trials to counter Impella criticism

The maker of the heart pump is seeking to quash doubts after two large observational studies suggested the product was more risky and pricey than alternative treatments.