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Medtronic pulls HeartWare HVAD pump from market amid recalls, patient deaths

The medtech said the move was influenced by growing evidence the system had higher mortality risks than comparable devices. FDA advised providers to use Abbott's HeartMate 3 as an alternative.

An AstraZeneca, Merck drug slows the return of genetic breast cancer. Will testing speed up?

Study results disclosed ahead of ASCO could make Lynparza a standard "adjuvant" treatment for people with an inherited form of breast cancer — as long as they know they have it. 

CMS' Fowler: More mandatory payment models likely

"I recognize those come with their own set of disadvantages ... But I support this direction," CMMI head Elizabeth Fowler said Thursday.

Former FDA official Abernethy joins Google health spinoff

The agency's former acting CIO pushed development of real world evidence as well as improved data sharing. At Verily, she'll head up the unit's clinical research business.

FDA warns device makers of falsified records at Italian ethylene oxide sterilization facilities

BD and Medtronic are among those that already recalled products processed by Steril Milano, accused by the agency of falsifying graphs and parameters of sterilization certificates for a variety of products dating back to 2016.

Cognoa's machine learning software for autism diagnosis gets FDA nod

The software as a medical device, which uses an algorithm, reports a positive or negative diagnosis based on analyses of videos of the child and other information. The product got FDA's breakthrough designation in early 2019.

Amid pricing tumult, iRhythm CEO resigns after 4 months in office

After taking over on Jan. 12, Mike Coyle stepped down Tuesday. CFO Douglas Devine will assume the role amid a search for a permanent replacement. Shares were down by nearly 17% Wednesday morning.

Abbott's COVID-19 testing surprise suggests demand softening faster than sector forecast

The medtech on Tuesday cut its 2021 outlook blaming a sharp, rapid decline in demand for its coronavirus-related tests on vaccinations. The sudden hit to test volumes could be a harbinger for the diagnostics sector.  

Abbott cuts 2021 outlook, blaming rapid decline in COVID-19 testing demand

CEO Robert Ford described a "sharp and rapid" drop-off in demand, a trend the company expects to continue. Shares slumped 7% on the news.    

Abiomed buys preCARDIA to bag breakthrough heart failure device

William Blair analysts had hopes the buy could help Abiomed move past "two years of commercial disruptions" to drive long-term growth.

FDA seeks 8% budget boost for CDRH to back resurgence of domestic device production

The Biden administration said its request for the Center for Devices and Radiological Health will help the U.S. reduce reliance on products from China and other countries and strengthen its ability to respond to emergencies.

Medtronic steps up robotics bet as its challenger to Intuitive starts clinical trial

The medtech giant seeks to double or triple sales in its 2023 fiscal year. However, analysts warned that near-term investments will pressure margins in the short term.

In first, FDA approves KRAS-blocking cancer drug from Amgen

After decades of scientists unsuccessfully targeting the KRAS gene, Lumakras is the first drug proven effective. The FDA Friday also approved companion diagnostics from Qiagen and Guardant Health.

UPDATED: May 29, 2021 at 12:35 p.m.

ACLA appeals dismissal of PAMA lawsuit, pushes legislative fixes

The lab trade group for Quest, LabCorp and others argues the Protecting Access to Medicare Act is a case of "harmful regulatory overreach" that forces an "unsustainable reimbursement model" on its members.

Swiss medtech sounds alarm as MDR erects barriers to EU market

The Swiss Medical Technology Association said the change will cost the industry it represents the equivalent of $126 million to meet new administrative requirements.

Rising hospital ransomware attacks could endanger patients, hit bottom lines hard, Moody's says

Systems have been rendered more vulnerable due to COVID-19 as more non-clinical employees work from home. The warning echos comments made recently by the FDA's cyber chief for medical devices. 

Analysts tip Edwards' US TAVR growth at 90% in April

A Jefferies review of hospital data suggests the medtech could comfortably beat the current analyst growth forecast, but comes with multiple caveats.

Medtronic revenue up 37% as electives make a comeback

CEO Geoff Martha told investors Thursday most businesses are returning to near pre-COVID-19 growth rates, though he admitted there is "work to do" in areas like neurovascular and diabetes.

MDR challenges remain as regulation goes into effect: MedTech Europe

The European trade group contends that while the Medical Device Regulation's May 26 effective date marks a significant milestone, hurdles limit industry’s ability to "seamlessly supply certified devices under the new rules."  

FDA draft guidances lay out postmarket medical device data requirements

Building on existing policy, one proposal deals with rules for Class II and III products while another relates to PMAs. 

MDR is live. Here are 5 things to know on where the rule stands.

The device industry has resolved some near term pressures as the EU's delayed landmark regulation comes into effect, but challenges related to IVDR, Brexit and more remain.

Senate confirms Chiquita Brooks-LaSure as head of CMS

AdvaMed and MDMA both called out the Medicare Coverage of Innovative Technology rule, now delayed, as a priority for the new administrator. President Joe Biden has yet to name an FDA chief.

Quest partners with Paige to create AI-enabled cancer pathology products

The two will initially focus on developing regulatory-approved products that support the diagnosis of solid tumors such as cancers of the prostate, breast, colorectal region and lung. 

HHS commits $4.8B to COVID-19 testing for the uninsured

The American Clinical Laboratory Association, with members including LabCorp and Quest Diagnostics, had urged the Biden administration in February to make more money available.

Ransomware, other cyber threats mount as medtech industry tries to adapt

"Everything is hackable," said Kevin Fu, the FDA's medical device cybersecurity chief, who noted that ransomware in particular can render a device useless.