FDA-cleared, wearable blood pressure device hits market

A cuff in the wrist watch band inflates to capture systolic and diastolic pressure.

By Maria Rachal • Dec. 21, 2018

BD gets 510(k) for viral gastroenteritis diagnostic

The panel reportedly delivers results in less than 3.5 hours.

By Maria Rachal • Dec. 21, 2018

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

Researchers advance 3D-printed, wirelessly-controlled ingestible

The multi-purpose device could spend a month or more in the stomach as a diagnostic tool or drug delivery mechanism.

By Nick Paul Taylor • Dec. 19, 2018

FDA draft guidance aims to clarify X-ray radiation rules

The agency also said it plans to harmonize its performance standards with those of the International Electrotechnical Commission to simplify compliance for global manufacturers.

By Susan Kelly • Dec. 17, 2018

Rapid diagnostic test detects Ebola, malaria in the field

The portable test can detect Ebola and other viruses in under 30 minutes from a single blood sample.

By Susan Kelly • Dec. 14, 2018

Grand jury indicts physician over alleged medical testing fraud

The indictment came days before the government settled a separate fraud case with an audiology practice.

By Nick Paul Taylor • Dec. 13, 2018

Apple EKG, artificial iris among FDA 2018 device decisions

De Novos are on the rise, but both premarket approvals and 510(k)s appear to be slightly down from 2017, according to nearly year-end data from FDA.

By Meg Bryant • Dec. 12, 2018

Merck taps Roche for Keytruda companion diagnostic

Roche will develop a test to identify patients with a certain biomarker known to make solid tumors vulnerable to treatment with the checkpoint inhibitor.

By Nick Paul Taylor • Dec. 12, 2018

Thermo Fisher gets FDA nod for plazomicin immunoassay

The antibiotic, marketed as Zemdri, is used to treat patients with complicated urinary tract infections.

By Susan Kelly • Dec. 11, 2018

Hologic begins selling 3-in-1 uterine scope

The device is intended to improve the procedure for treating uterine conditions by avoiding the need to change from a diagnostic to an operative scope.

By Susan Kelly • Dec. 11, 2018

FDA guide unveils vision for cancer diagnostics

The proposal came the same day lawmakers released an updated draft bill that would grant FDA authority to oversee in vitro clinical tests, such as test kits and laboratory developed tests.

By David Lim • Dec. 7, 2018

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.

By Susan Kelly • Dec. 5, 2018

ACLA appeals lab payment suit to higher court

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

By David Lim • Dec. 5, 2018

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.

By Susan Kelly • Dec. 4, 2018

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.

By Susan Kelly • Dec. 3, 2018

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.

By Susan Kelly • Dec. 3, 2018

LabCorp cuts its profit outlook, citing volume shortfall

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

By Susan Kelly • Dec. 3, 2018

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.

By Maria Rachal • Nov. 30, 2018

NIST takes early step toward bringing photonic chips into healthcare

The technology opens up new avenues for research by transmitting data via light waves, not electric current.

By Nick Paul Taylor • Nov. 29, 2018

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.

By Nick Paul Taylor • Nov. 29, 2018

Quest closes buy of Midwest lab services business

Completion of the deal for Columbia, Missouri-based Boyce and Bynum Pathology Laboratories comes as the lab services giant prepares to release financial results later this week.

By Susan Kelly • Updated Feb. 12, 2019

Metagenomic sequencing shows promise in diagnosing airway infections

The test zeroed in on causative pathogens in lower respiratory tract infections, which are the leading cause of infectious disease-related deaths globally yet have been notoriously challenging to diagnose.

By Nick Paul Taylor • Nov. 28, 2018

Beckman initiates Class I recall of flow cytometers

FDA is concerned inaccurate results provided by the devices could lead to serious injuries or deaths.

By Nick Paul Taylor • Nov. 22, 2018

Millennial to menopausal, women's health is fertile space for startups

Early-stage investors have increased support for female-specific devices and direct-to-consumer diagnostics in the last five years, as the women’s health market is poised to reach $50 billion globally by 2025.

By Maria Rachal • Nov. 14, 2018

3D printing poised to disrupt healthcare

Health industry types are "100% convinced, and rightly so, that [3D printing] will be a core part of their business in five to 10 years," ISG's Michael Harmon said.

By Meg Bryant • Nov. 12, 2018