Fierce Medical Devices

An agency advisory panel voted against recommending clearance for Neuronix's transcranial magnetic stimulation device, which targets the memory and learning centers of the brain during cognitive therapy sessions.

A new toilet seat-based monitoring system aims to spot the signs of congestive heart failure in the privacy of the home, with the noble goal of lowering hospital readmission rates. Developed by researchers at RIT, the sensors in the high-tech seats will be privy to a person’s heart rate, blood pressure and more.

The FDA has approved another one of its breakthrough devices: an implant from Impulse Dynamics designed for patients with chronic heart failure who aren’t able to use a pacemaker or standard cardiac resynchronization therapy.

Dialysis provider Fresenius Medical Care has created a new global medical office that will head up its work in clinical science and coordinate knowledge and practice sharing across the company’s global network of clinics.

The FDA has issued two warning letters to breast implant manufacturers—including Sientra and two Johnson & Johnson subsidiaries—in the middle of newly galvanized agency probes into the long-term safety and biocompatibility of silicone-based implants. The March 18 letters chided the companies for failing to complete postmarket evaluations of their products.

Scientists have been working on new ways to increase the sensitivity of blood tests for detecting cancer, known as liquid biopsies. Now, a consortium of scientists from three top U.S. cancer research institutions, along with Illumina and Grail, have developed a new assay that could detect multiple targetable cancer mutations with a high degree of accuracy.

The Chan Zuckerberg Initiative is awarding $17 million to 17 scientists across a range of technical disciplines to develop new advances in digital microscopy that may allow researchers and physicians to peer into the subtleties of disease.

Biotronik has received FDA approvals for two families of high-voltage cardiac rhythm management devices. The company now has a total of six FDA-approved devices for treating and resynchronizing tachycardia and arrhythmias.

IRhythm Technologies has found that its continuous ECG monitoring chest patch was not only able to improve the diagnosis of atrial fibrillation but also helped lower the numbers of emergency room visits and hospitalizations by shifting patients to outpatient cardiology settings.

2016 Fierce 15 company PowerVision is being picked up by Novartis’ heavyweight eye-care unit Alcon, in a $285 million deal for its innovative, fluid-based intraocular lens implant for people with cataracts.

After canvassing more than 400,000 people across all 50 states in just eight months, Apple has finished a virtual investigation of its smartwatch’s ability to alert users to irregular heart rhythms possibly linked to atrial fibrillation. It was one of the largest studies of its kind.

The FDA has begun to re-evaluate the state of the science around the materials used in long-term medical implants, pointing to a growing body of evidence that suggests a subset of patients may be predisposed to painful responses to the devices.

Stryker has acquired OrthoSpace, developers of a therapy for severely torn rotator cuffs, in a deal worth up to $220 million, split evenly between upfront cash and future milestone payments.

Ortho Clinical Diagnostics has received a CE mark for its new multitest platform that allows laboratories to run two in vitro diagnostic tests simultaneously on one slide.

Wearable bioelectronics developer Cala Health has launched a collaboration with Massachusetts General Hospital to help build out its noninvasive nerve stimulation platform for chronic diseases.

FundamentalVR has unveiled the addition of advanced haptic gloves to its virtual reality training system for surgeons, which allow them to feel the shape, texture, weight and movement of simulated three-dimensional objects.

Smith & Nephew has moved to absorb regenerative medicine developer Osiris Therapeutics in a $660 million deal that the company hopes will expand and accelerate its wound care business.

Short seller Kerrisdale Capital has launched a new attack on iRhythm Technologies, manufacturers of the Zio heart monitor patch, based on what it describes as a looming crisis over the reimbursement structure for its main product.

Microsoft aims to bring its coding skills to bear on biotech, with the goal of building an end-to-end platform for programming the biology of living cells to better produce new medicines and potentially materials that could be applicable to a range of industries.

OnMed's self-contained medical unit contains private video booths that allow physicians to remotely take vital signs and diagnose conditions, and includes a robotic minipharmacy that can dispense medications.