6 reasons you shouldn’t bet on blockchain disrupting healthcare

Blockchain is the big buzzword these days, bruited as a disruptive force for industries covering the spectrum. But there seems to be little understanding of what exactly “blockchain” means, let alone how it could affect so many different markets so profoundly. Simply put, a blockchain is a decentralized database with tight rules about how data […]

Integer to deal surgical, orthopedics assets to MedPlast for $600m

Integer Holdings (NYSE:ITGR) plans to sell its advanced surgical and orthopedic assets to MedPlast for $600 million in a deal that will double MedPlast’s top line and bolster the balance sheet for Integer, which missed expectations with its first-quarter earnings. Proceeds from the all-cash deal, announced yesterday and expected to close during the third quarter, are

FDA OKs Opus breast implant line from Sientra, with Lubrizol manufacturing

The FDA this week granted a pre-market approval supplement to Sientra (NSDQ:SIEN) for its Opus line of silicone breast implants. The implants are made in Wisconsin by Lubrizol LifeSciences subsidiary Vesta, which inked a contract manufacturing deal with Sientra back in August 2016. Sales of Sientra’s silicone breast implants ground to a halt in the autumn of 2015, when […]

Nexcore Technologies, Phase 2 Medical rebrand as NextPhase Medical Devices

Nexcore Technology, which last year acquired Phase 2 Medical Manufacturing, said this week that it’s merging the operations into a new contract manufacturing entity, NextPhase Medical Devices. NextPhase, which is owned by private equity shop Kidd & Co., is a low- to medium-volume outsource partner based in Waldwick, N.J., and facilities in Rochester, N.H., and

Abiomed agrees to pay $3 million to settle kickbacks allegations

Federal prosecutors said today that Abiomed (NSDQ:ABMD) agreed to pony up more than $3 million to settle allegations that it wined and dined physicians to induce them to use its Impella heart pump. The U.S. Justice Dept. said that Danvers-based Abiomed agreed to settle the allegations for $3.1 million after a whistleblower’s lawsuit – which […]

Medtronic recalls 48 CRM devices on arcing risk

Medtronic (NYSE:MDT) informed physicians last month of a problem with 48 of its cardiac rhythm management devices that’s prompting a Class I recall of the devices. The recall affects cardiac resynchronization therapy defibrillators and implantable cardioverter defibrillators that were “sent through a manufacturing sequence that introduced the potential for internal arcing during high-voltage charging, leading […]

Integer shares jump on strong Q4 earnings beat

Integer Holdings (NYSE:ITGR) yesterday handily topped the consensus earnings expectation and met sales forecasts with its fourth-quarter and full-year results. The Frisco, Texas-based medical device contract manufacturer posted profits of $54.3 million, or $1.68 per share, on sales of $390.5 million for the three months ended Dec. 29, 2018, for a bottom-line gain of 585.0% on

IRS won’t enforce penalties on medical device tax

The U.S. Internal Revenue Service yesterday said it won’t enforce penalties on companies making late payments on the medical device tax for the first three months of this year. The 2.3% excise tax on U.S. medical device revenues was in effect for two years before a two-year moratorium went into effect for 2016 and 2017. It went […]

The medical device tax is back in effect

The ringing in of the new year also rang in the return of the medical device tax, a 2.3% levy on medtech sales that went back into effect after a two-year pause. The U.S. Congress closed out 2017 without taking action to delay or repeal the medtech tax, despite broad support from both sides of the […]

Medicare finalizes cuts to value-based healthcare programs

The Centers for Medicare & Medicaid Services yesterday finalized cuts to a trio of bundled payment pilot programs aimed at lowering healthcare costs and improving outcomes. The federal health insurer cut the Comprehensive Care for Joint Replacement Model, or CJR, effectively in half, from 67 geographic areas participating to 34, meaning about 470 hospital participants instead of 800. […]

Jury acquits defendant in shooting death of Medtronic rep

A San Francisco jury yesterday acquitted the defendant of charges that he killed former Medtronic (NYSE:MDT) sales rep Kate Steinle. Steinle, 32, was walking along the waterfront of the Embarcadero in San Francisco with her father and a friend on July 1,. 2015, when she was shot in the back, allegedly by Jose Ines Garcia Zarate, an […]

FDA clears AliveCor’s KardiaBand ECG for Apple Watch

AliveCor said today that the FDA cleared its KardioBand electrocardiogram device for the Apple Watch, designed to monitor for early signs of atrial fibrillation. First introduced in March 2016, KardiaBand is the first medical device accessory to be cleared by the federal safety watchdog for the Apple Watch, Mountain View, Calif.-based AliveCor said. It’s designed to display […]

Trump nominates pharma insider Azar to lead HHS

The Trump administration today nominated Alex Azar, who spent nearly 10 years at Eli Lilly (NYSE:LLY) after working in the second Bush administration, as secretary of the U.S. Health & Human Services Dept. The former HHS head, Dr. Tom Price, resigned in September after days of fending off criticism over chartered flights he took on the public dime. […]

FDA puts Second Sight Medical’s next-gen Orion ‘bionic eye’ on the fast track

Second Sight Medical (NSDQ:EYES) said today that the FDA put its Orion “bionic eye” on the fast track to approval. The Orion device is a cortical visual prosthesis that uses a camera and a brain implant to bypass the optic nerve in visually impaired patients. The federal safety watchdog put the device on its expedited […]

Haemonetics to cut 11% of workforce

Haemonetics (NYSE:HAE) said today that it plans to cut roughly 11% of its global workforce as it looks to pare $80 million from its annual cash burn by the end of fiscal 2020. The Braintree, Mass.-based blood management company said it plans to eliminate 350 positions by the end of its fiscal year in April. The company reported […]