The Latest

• 

  Hologic to lay off 190 workers as it closes European facilities

  Three months after announcing unspecified international facility closures, Hologic has disclosed the number of affected employees and estimated $12.2 million in severance costs.

  Updated May 6, 2024

  Diagnostics

• 

  FDA qualifies Apple Watch AFib feature for use in clinical trials

  Officials will accept atrial fibrillation data collected by the wearable as a secondary endpoint in studies of cardiac ablation devices. 

  Clinical Trials

• 

  QuidelOrtho names ex-Abbott exec Brian Blaser as CEO

  Blaser is coming out of retirement to take charge of QuidelOrtho, after the diagnostics company fired former CEO Doug Bryant in February.

  COVID-19

• 

  Cue Health to cut 230 employees

  Declining COVID-19 test sales have forced Cue to eliminate hundreds of jobs in multiple rounds of layoffs over the past several years.

  Medical Devices

• 

  Lab test overhaul: FDA to regulate LDTs as medical devices

  Stricter review of new tests developed by laboratories is coming, but some fear the changes will be expensive, time-consuming and discourage innovation.

  Policy & Regulation

• 

  UK sets out position on regulating AI as a medical device

  Some AI products that currently can be put on the market without conformity assessment will move to a higher risk class, requiring more scrutiny.

  Digital Health

• 

  Quest to ramp up AI capabilities with purchase of PathAI’s diagnostic lab

  PathAI is selling its diagnostics assets, including a Tennessee laboratory, but will continue to support its biopharmaceutical customers.

  M&A

• 

  Cardinal receives FDA warning letter over unapproved syringes

  The agency has recently increased scrutiny of plastic syringes made in China because of safety concerns, including blocking imports from two Chinese manufacturers.

  Medical Devices

• 

  Philips reaches major settlements related to respiratory devices recall

  A judge recently finalized an economic claims settlement, and Philips said it reached an agreement on medical claims.

  Legal

• 

  Medline to buy Ecolab’s surgical products for nearly $1B

  The medical products supplier will acquire Ecolab’s sterile drapes and fluid temperature management systems.

  Medical Devices

• 

  Senseonics gets FDA clearance to pair CGM implant with insulin pumps

  Analysts said the designation and planned one-year sensor could help Senseonics’ device appeal to more patients.

  Digital Health

• 

  Labcorp gains FDA approval for companion diagnostic to Pfizer gene therapy

  The test would determine if patients are eligible for Pfizer’s new hemophilia B treatment by detecting if they have been exposed to a virus that could make the gene therapy less effective.

  Policy & Regulation

• 

  FDA defends LDT final rule, while critics fear it upends lab industry

  The new policy aims to ensure important diagnostics remain available to patients, but some experts caution the increased regulatory burdens could slow access to testing.

  Policy & Regulation

• 

  Abbott wins FDA approval for Esprit resorbable scaffold

  While RBC analysts wrote there’s “strong appetite” for the system, BTIG said the need to train centers could result in a gradual launch.

  Medical Devices

• 

  Hologic to buy Endomagnetics for $310M

  Endomagnetics, which makes guidance technology for breast cancer surgery, brought in about $35 million in revenue last year.

  Medical Devices

• 

  Medtronic to lay off 44 employees in California

  Medtronic’s latest layoff plan adds to what has become a long list of job cuts for the medical device industry this year.

  Medical Devices

• 

  FDA finalizes lab developed test rule despite industry opposition

  Risks associated with the tests have increased, requiring greater oversight to protect patients, the agency contends.

  Policy & Regulation

• 

  Philips agrees to $1.1B settlement of US respiratory recall lawsuits

  CEO Roy Jakobs said on a first-quarter earnings call that “for the U.S., this is as final as it can get.”

  Medical Devices

• 

  Medtronic wins FDA approval for Inceptiv closed-loop spinal cord stimulator

  Evercore analysts said the launch could help Medtronic regain market share in the coming quarters.

  Medical Devices

• 

  Livanova says patient data obtained in 2023 cyberattack

  Livanova learned that an unauthorized party obtained patient data, including Social Security numbers and health conditions, during last year’s attack.

  Cybersecurity

• 

  Fresenius Medical Care recalls 2M dialysis devices over toxin exposure risk

  Nearly 2.2 million devices are affected by the recall. Fresenius Medical Care will not have to remove products due to the issue.

  Medical Devices

• 

  Edwards gets Q1 boost as Pascal valve repair sales ramp up

  New mitral and tricuspid valve treatments are attracting strong demand, but analysts said transcatheter aortic valve replacement sales were shy of expectations.

  Medical Devices

• 

  Infutronix infusion pump recall linked to 6 injuries, 1 death

  The FDA’s recall notice sheds light on the impact to patients weeks after the company told customers it would pull Nimbus pumps from the market.

  Medical Devices

• 

  Labcorp to acquire Invitae’s assets for $239M

  William Blair analyst Andrew Brackmann said Labcorp is being aggressive in its M&A strategy, after announcing last month it would buy several of Bioreference Health’s testing businesses.

  M&A

• 

  Judge approves settlement of more than $500M from Philips recall

  Philips could be on the hook for more costs if eligible claims for recalled or returned respiratory devices exceed the amount agreed to in the settlement.

  Legal

More stories