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Rapid test for brain injury gets FDA breakthrough status

The test measures protein biomarkers released from the brain into the bloodstream after a head trauma, producing results in as little as 90 seconds.

Medical Devices

Device that extracts brain tumors gains FDA breakthrough status

After yielding successful results in rats, the device is being redesigned for human use with the goal of obtaining approval to start trials by the end of the year. 

Medical Devices

FDA finalizes guidance to strengthen its recall processes

The agency's move to improve its recall protocol across all categories follows a 2017 report from the Office of Inspector General of HHS that was particularly critical of FDA's food recall process.

Medical Devices

FDA to exempt handful of devices from 510(k) requirements

The latest deregulatory step does not exempt the products from other mandates such as registration and listing, labeling, good manufacturing practices and medical device reporting requirements.

Medical Devices

Precision medical imaging set for explosive growth, analysts say

Frost & Sullivan believes the market will grow to $8 billion by 2027, up from $120 million in 2017.

Imaging

India seeks to lure medtech to growing market

Only about 400 of the roughly 5,000 medical devices marketed in India are currently regulated. 

UPDATED: Feb. 12, 2019 at 10:16 a.m.

Medical Devices

LabCorp diagnostics' operating income tumbles as PAMA hits home

Reimbursement changes wiped $18 million off LabCorp's adjusted operating income, contributing to a 22% drop at the diagnostics unit.

Diagnostics

Microsoft debuts healthcare messaging features, new bot service

Microsoft Care Team users can now view integrated EHR data on their mobile device. The company will showcase these and other tools at HIMSS 2019 in Florida next week.

Digital Health

Breast implant-associated lymphoma tied to at least nine US deaths, FDA says

The agency reported at least 457 unique cases of a form of non-Hodgkin lymphoma potentially linked to the device. The updated data comes weeks before a March advisory panel meets to examine known breast implant risks.

Medical Devices

Medtronic nabs expanded indication for Pipeline Flex embolization device

The device, first approved for endovascular treatment of adults with certain large or giant wide-necked intracranial aneurysms, is now also indicated for patients with certain small or medium aneurysms.

Medical Devices

FDA categorizes Edwards' cardiac diagnostic recall as Class I event

Edwards pulled the catheters from the market after learning that an assembly error was causing the devices to display inaccurate information.

Policy & Regulation

EHR vendor Greenway Health hit with $57.25M False Claims fine

In addition to misrepresenting the capabilities of its software, the company is accused of falsely obtaining 2014 Edition certification status for its Prime Suite EHR.

Legal

Smith & Nephew has Q4 sales miss as headwinds persist

Falling sales of arthroscopic enabling technologies led the London-based company to fail to meet analyst revenue expectations for the quarter.

Medical Devices

FDA draft lays out submission paths for combo products

Commissioner Scott Gottlieb said the agency will develop additional guidances outlining specific premarket considerations for combo products.

Medical Devices

Boston Scientific targets structural heart, international market growth in 2019

A near-constant stream of acquisitions defined the device giant's 2018. Now, it's looking ahead to product launches in the U.S., Europe and Japan.

Medical Devices

Cognoa's autism devices win breakthrough status

The special FDA designation covers the company's digital devices designed to improve the diagnosis and treatment of autism.

Policy & Regulation

Current Health's wearable vital sign monitor gets FDA nod

The 510(k) clearance covers an arm-worn device that monitors variables such as oxygen saturation and alerts healthcare professionals to deviations.

Policy & Regulation

Teleflex granted FDA approval for vascular closure device

The product is designed to seal femoral punctures following vascular access medical procedures.

Medical Devices

Trump light on trade details in State of the Union address

The President's comments on trade were short and direct, calling for passage of the United States-Mexico-Canada Agreement (USMCA) and the lesser-known Reciprocal Trade Act.

Policy & Regulation

FDA redefines 'least burdensome' as critics fear chilling effect on reviewers

A watchdog argues the guidance is the agency's latest step to speed device approvals at the expense of robust patient protection.

Medical Devices

FDA warns cardiologists of high mortality in Abiomed post-approval study

The 17% survival rate in the post-approval study of its Impella temporary right heart pump system prompted FDA to write to healthcare professionals and wiped 6% of Abiomed's stock.

Medical Devices

BD results largely expected, beats on revenue

One year after closing the acquisition of C.R. Bard, the company said it is on track to achieve expected cost and revenue goals.

Medical Devices

Healthcare groups urge CMS to keep coverage of NGS cancer tests

Sixty-three healthcare companies and organizations argued the agency's approach to covering next generation sequencing will restrict cancer patients' access to essential tests.

Policy & Regulation

Cook Medical aortic dissection device gets FDA approval

The device is designed to repair Type B dissections of the descending thoracic aorta in a minimally invasive procedure.

Medical Devices

Stryker issues voluntary field action after 6 deaths linked to defibrillator bug

The device giant obtained the product as part of its $1.28 billion acquisition of Physio-Control in 2016.

Medical Devices