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OIG finds Medicare overpaid $34M to device suppliers over three years

The overpayment stems from improper billing for prosthetics and other devices used at inpatient facilities.

Medical Devices

ACLA appeals lab payment suit to higher court

A watchdog report on Medicare lab payments will not help the industry's case, analysts said.

Policy & Regulation

FDA endorses open database for genetic variants

The agency said it hopes the move will encourage database administrators to submit genetic variant information to publicly accessible databases, with the aim of spurring advancements in precision medicine.

Policy & Regulation

FDA classifies Medtronic's ventilator correction a Class I recall

The software update addresses user interface problems that led Australian regulators to suspend the device.

Medical Devices

ResMed buys maker of COPD, asthma monitoring platform

The acquisition of Propeller follows a growing trend by device makers to acquire or partner with digital technology companies. 

Medical Devices

8 medtech companies get leg up from FDA for opioid devices

Winners of the agency's Innovation Challenge to combat opioid abuse now have access to closer collaboration with FDA as they look to jointly fast track their products to market. 

Medical Devices

Medtronic AFib study combines hot, cold ablation techniques

Atrial fibrillation treatments are a high-growth business for Medtronic, which competes against Boston Scientific and Abbott in the $4 billion market.

Medical Devices

NIH completes enrollment in huge adolescent neuroimaging study

Researchers will use fMRI to monitor neurological changes in nearly 12,000 children over the next 10 years.

Research

Telehealth uptake surprisingly low among physicians, AMA finds

Large and specialty practices are more likely to use telehealth, suggesting that implementation costs are a barrier, according to a new study in Health Affairs.

Digital Health

Medtech R&D adapting under new pressures, industry study shows

The shift to value-based payment models and already tight profit margins are ratcheting up pressure, but the device makers are adjusting their R&D investment strategies in response.

Medical Devices

UK and EU inch toward regulatory cooperation after Brexit

As the leave date looms next March, a political declaration notes the bloc will explore the possibility of cooperation by U.K. authorities with agencies like the European Medicines Agency.

Policy & Regulation

FDA's De Novo pathway is about to get a makeover

"Particularly with really low risk devices, it can be challenging both from FDA's perspective and industry's perspective in terms of how much data is needed," Allyson Mullen, an attorney at Hyman, Phelps & McNamara told MedTech Dive.

Medical Devices

Medicare could overpay billions for lab tests: GAO

Medicare's new method of calculating payment rates for laboratory tests was intended to save the government money but could instead end up costing CMS as much as $10.3 billion over three years.

Policy & Regulation

LabCorp cuts its profit outlook, citing volume shortfall

The announcement follows a profit warning just two days earlier from rival Quest Diagnostics.

Diagnostics

FDA OKs first test to detect herpes in newborns

The Meridian Bioscience test uses a saliva swab to detect cytomegalovirus DNA and may help identify the virus in newborns more quickly.

Diagnostics

Canada vows to strengthen device regulation following media probe

More stringent approval requirements and the mandatory publication of clinical data are among the changes being discussed.

Medical Devices

FDA issues draft guidance on blood glucose monitors

The agency said distinguishing between test systems used in healthcare settings and those for use by patients at home will improve product safety and effectiveness of the devices.

Medical Devices

FDA offers more study options for CLIA waivers in redrafted guidances

The agency added new test design alternatives for manufacturers seeking waivers for IVD devices, a nod to a push from AdvaMed and others.

Policy & Regulation

GE, VA partner to accelerate creation of 3D medical models

The use of software tailored to the medical sector is expected to slash model creation timelines.

Medical Devices

Telemedicine use among commercially insured skyrocketed since 2005

Driven by payer coverage for direct-to-consumer telemedicine, annual visits increased by 52% annually from 2005 to 2014 and a whopping 261% from 2015 to 2017, according to a JAMA study.

Digital Health

Fighting for market share, LabCorp and Quest plan expansions

The laboratory testing giants are opening new sites on opposite coasts as they pursue market share gains.

Diagnostics

HHS outlines broad plan to reduce EHR burden

The 74-page draft strategy, required by the 21st Century Cures Act, focuses on reducing time and effort tied to regulatory reporting requirements and increasing functionality and user-friendliness of EHRs.

Policy & Regulation

BD, Microsoft create software to identify drug diversion

The algorithms analyze dispensing data to spot suspicious activity by clinicians.

Digital Health

CVS-Aetna megamerger finalized

The total value of the acquisition, including assumption of Aetna's debt, clocks in at $78 billion. The union creates the second biggest private company by revenue after Walmart.

Legal