SEC charges Theranos, CEO Holmes with ‘massive fraud’

The US Securities and Exchange Commission today charged controversial blood-testing developer Theranos, founder & CEO Elizabeth Holmes and former prez Ramesh Balwani with “massive fraud” – charges which Theranos and Holmes have agreed to resolve, according to the SEC. Charges include claims that the company raised more than $700 million from investors in “an elaborate,

Unsealed Abiomed whistleblower suit reveals claims of retaliation

Newly unsealed court documents related to an alleged kickback scheme that Abiomed (NSDQ:ABMD) agreed to settle last week for $3 million revealed claims of retaliation against the whistleblower in the case. The plaintiff-relator in the case, Max Bennett, accused the Danvers, Mass.-based company of firing him in retaliation for speaking out on the allegations that the […]

Former GE CEO Jeff Immelt had a lasting impact in medtech: Here’s how

No matter how you feel about his tenure leading the industrial conglomerate, former GE CEO Jeff Immelt helped shape medtech by filling the industry’s corner offices with former employees. The right leader at the right company, at the right time, can have an effect that last decades – not only through their own actions but

Innovatus closes buyout of Bayer’s European imaging device service biz

Innovatus Imaging said yesterday it closed its acquisition of the European Bayer Multi Vendor Service business. Pittsburgh, Penn.-based Innovatus said that as part of the acquisition, the business will now operate under the moniker Innovatus Imaging Europe B.V. “The acquisition of the European Bayer MVS business and its team’s extensive expertise is the next step

How Medrobotics’ CEO thwarted possible corporate espionage

Medrobotics CEO Samuel Straface has a habit of being last out the door – a habit that may have saved his company from corporate espionage. Good leadership isn’t a trait that manifests itself only when there’s a team to oversee. It’s a persistent quality that, when managed correctly, requires constant and consistent effort and can

Report: Amazon gearing up for entry into medical supplies biz

Amazon (NSDQ:AMZN) is looking to up the ante in its medical supplies business and turn the unit into a major supplier to US hospitals and clinics, according to a Wall Street Journal report. The online mega retailer has initiated a trial of a new system testing to see if it can use its Amazon Business site to supply

Private equity-backed Regatta Medical buys majority stake in Resonetics

Private equity firm GTCR’s portfolio company Regatta Medical said today it acquired a majority stake in Resonetics, with its current management team led by CEO Tom Burns slated to continue their roles with the company. The deal, which included an increased investment from previous owner Sverica, is slated to close sometime in early February, Boston-based

Antidote looks to leverage AI, travel e-commerce tech to improve clinical trial enrollment

Clinical trial artificial intelligence company Antidote is looking to improve access to and enrollment in clinical trials using technology from the e-commerce world, according to a Wired report. Former travel and airline fare aggregator Kayak VP Pablo Graiver is heading the operation, which streamlines access to clinical trials for patients seeking them out.   Read

Report: CMS nixes plans for pathway for expedited medical device coverage

The Centers for Medicare & Medicaid Services has cancelled plans to create a new regulatory pathway that aimed to accelerate medicare coverage for medical devices, according to a ModernHealthcare report. The federal agency reportedly withdrew the proposition, known as Excite, from review at the White House’s Office of Management and Budget this month, nine months after […]

J&J chief Gorsky bullish on tax reform, plans $16B in repatriated overseas cash

Johnson & Johnson (NYSE:JNJ) chief executive Alex Gorsky is bullish on the newly passed US tax reform, according to a new interview with CNBC. Gorsky said that with the passing of the new tax reform bill last month, New Brunswick, N.J.-based Johnson & Johnson plans to repatriate $16 billion in overseas cash, according to the interview. […]

Zimmer Biomet wins FDA nod for Sidus stem-free shoulder system

Zimmer Biomet (NYSE:ZBH) said today it won FDA clearance for its Sidus stem-free shoulder system. The newly cleared Sidus system is designed as a total shoulder arthroplasty solution for patients with good bone stock with either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head or those who’ve had previous surgeries of the shoulder that […]

Report: Korea to adopt ‘fast-track’ approval for next-gen med devices

South Korea’s regulatory bodies have agreed to adopt a “fast-track” approval process for next-generation medical devices, according to a new report from the Korea Herald. The policies are being enacted to promote medical devices whose success is dependent upon entering the market ahead of their competitors, and would allow devices to be certified on a […]

Beta Bionics raises $2m

Beta Bionics has raised $2.4 million in a new round of equity and securities financing, according to an SEC filing posted this week. A total of 11 anonymous investors have participated in the round, though the company has not yet stated who has joined or how it plans to spend funds raised. Read the whole […]

Report: Value-based medtech payment models lack appropriate quality measures

A new report from Discern Health and supported by industry group AdvaMed claims that current value-based payment models lack quality measures which effectively assess medical technology value. In the report, investigators identified what they claimed to be “significant gaps” in eight clinical areas it studied that included medical devices indicated to treat those conditions. Report […]

GE Healthcare, Lifespan ink data analytics deal looking to cut $182m in costs, improve patient care

GE Healthcare (NYSE:GE) and healthcare provider Lifespan said this week they inked a collaborative deal as Lifespan looks to use GE’s services and systems to reduce its costs by approximately $182 million while improving patient care. Through the deal, which is slated to cover six years, GE Healthcare will aid Lifespan in improving patient flow, increasing