FDA issues Class 1 recall for Hamilton Medical ventilators

Ongoing issues that have dogged Hamilton Medical ventilators have triggered a second Class 1 recall of the devices this year. This time the Swiss-based company is recalling 1,126 of the machines from U.S. healthcare providers.

DJO Global launches new total knee replacement

Vista, CA's DJO Global launched the Empowr 3D Knee at the annual meeting of the American Association of Hip and Knee Surgeons in Dallas, TX.

Allergan beefs up in aesthetics with implant purchase. Does M&A suitor Pfizer approve?

Big Pharma Allergan announced it is bulking up in aesthetics by purchasing London's Northwood Medical Innovation, maker of the earFold device for the correction of prominent ears, with or without asymmetry, in patients 7 or older. The deal marks the third Allergan device deal in recent months.

Biosensors sells out to Chinese private equity firm for $787M

Singapore devicemaker Biosensors International is handing over the rest of its business to the private equity arm of China's Citic Group for 1.1 billion Singapore dollars ($787 million), a week after Citic made a takeover bid for the company.

Boston Scientific files patent infringement suit against Edwards' Sapien 3 TAVR

Boston Scientific is alleging that Edwards' Sapien 3 TAVR infringes its patents related to adaptive sealing technology in an intellectual-property lawsuit filed against the competitor in Germany.

FDA adds another artificial kidney to its Expedited Access Pathway program

A surgically implanted artificial kidney under development at the University of California, San Francisco, has been accepted into the FDA's Expedited Access Pathway for "breakthrough" technologies that debuted just 6 months ago.

Dx Digest: Illumina launches $250M share repurchase program; Foundation Medicine stumbles with Q3 earnings miss

In this week's Dx Digest, Illumina unveiled a $250 million share repurchase program, Quest Diagnostics inked a deal with lab data analytics firm Medivo to use its data sets to help match patients to new drug therapies, and Foundation Medicine reported a beat on revenues for the third quarter, even though it missed the Street's expectations on earnings.

Amid CMS incentives and patient deaths, interest in diagnostics and devices for sepsis is rising

The Centers for Medicare & Medicaid Services are set to add sepsis to the list of conditions that will factor into its hospital-acquired condition reduction program starting in fiscal year 2017.

NIH study finds noninvasive electrical brain stimulation has potential to fight obesity

A NIH study came out in support of transcranial direct current stimulation, prompting the agency to say that the noninvasive stimulation technique has the potential to promote weight loss.

French robotic surgery company Medtech S.A. reports $15M private equity financing

Medtech S.A. announced a $15 million financing, as the Montpellier, France-based robotic surgery company commercializes its FDA-cleared device for neurosurgery across the world and seeks U.S. approval of its spinal surgery device. The transaction consists of the sale of convertible notes and warrants to purchase common stock to investor Ally Bridge Group, a private equity firm focused on healthcare.

Medtronic axes 150 jobs in new Irish tax domicile

Cue the Medtronic-Covidien layoffs. Medtronic is cutting 150 jobs in Ireland, months after closing its megadeal with Covidien and shifting its domicile to the country to enjoy the benefits of a lower tax rate.

Study: Intra-aortic balloon pumps show little help, possible increase in mortality in worst cases

A Japanese study of intra-aortic balloon pumps appears to indicate the devices do little to improve outcomes for patients with acute cases and may increase the chances of death.

Theranos CEO heeds call for transparency for proprietary technology

Theranos has been responding to mounting backlash over its testing technology, with CEO Elizabeth Holmes saying last week that the company would publish data validating the accuracy of its tests after The Wall Street Journal called its business model and testing devices into question. Now Holmes is reaffirming that pledge, promising to boost transparency amid public fallout.

Medtronic releases health economics study of its drug-coated balloon at Las Vegas conference

Medtronic's data dump at the Vascular Interventional Advances conference in Las Vegas consisted of a health economics study of its In.Pact Admiral drug-coated balloon for peripheral artery disease and two-year clinical data of its Valiant Captivia Thoracic Stent Graft System.

Glaukos settles stent patent dispute with Transcend Medical

Glaukos has settled a patent infringement spat with Transcend Medical. Glaukos will not sue Transcend for patent infringement in connection with its CyPass Micro-Stent. In return, Transcend will not challenge any of Glaukos' patents and will make quarterly royalty payments of 1% of net sales of CyPass until April 2022.

Roche launches rapid HIV, hep C tests in Europe

Roche is rolling out rapid tests for HIV, hepatitis C and hep C genotyping in Europe, continuing its molecular diagnostics winning streak a couple of weeks after scoring FDA approval for related tests and unveiling promising numbers for its testing business.

Empatica eyes delivery of wearable epilepsy device following successful crowdfunding campaign

Empatica, which had a wildly successful crowdfunding campaign earlier this year for its wearable device that tracks stress, epileptic seizures, activity and sleep, hopes to begin delivery for its Embrace technology by next month.

Neuromodulator and artificial kidney to be reviewed under FDA's Expedited Access Pathway

A neuromodulator made by Boston's PathMaker Neurosystems and Cedars-Sinai Medical Center's Wearable Artificial Kidney just became some of the first devices to be accepted into the FDA's Expedited Access Pathway for "breakthrough" devices. The development is a win for the product sponsors, and also for the FDA, whose efforts to promote the 6-month-old pathway have resulted in only one other device making it into the EAP pipeline.

Fractyl gains traction with balloon ablation device for Type 2 diabetes

As scientists target gastrointestinal tract procedures as a way to treat Type 2 diabetes, Fractyl Labs is forging ahead with its balloon ablation device for the disease to cash in on the trend.

Conventus bags $21M in equity to commercialize minimally invasive implants to treat fractures

Minnesota's Conventus Orthopaedics has raised $21 million in equity to support its implants for fractures of the distal radius and shoulder. The latest funding round brings the company's equity haul to around $46 million, in addition to debt financing of about $10 million, SEC filings show.