Fierce Medical Devices

The FDA outlined a new pathway for the expedited approval of medical devices, diagnostics and certain combination products that aim to improve upon the safety of those currently on the market.

About 10 months after first announcing the move, Google has subsumed the healthcare-focused efforts of U.K.-based artificial intelligence firm DeepMind—and with them, its data-sharing partnerships with multiple National Health Service hospitals.

Amgen has tapped Adaptive Biotechnologies to deliver next-generation sequencing assays as it moves drugs toward approval. Under a four-year agreement, Adaptive’s clonoSEQ Assay will be used to assess minimal residual disease in clinical trials.

Abbott has received European approvals for two devices designed for children and infants with life-threatening heart defects—including the world’s smallest mechanical heart valve and a separate implant designed for the tiniest babies.

Using ultra-small device implants being developed by Iota Biosciences, Astellas Pharma hopes to explore new methods of delivering diagnostics and therapies that could work in concert with traditional treatments—or even replace them.

CMR Surgical has raised £195 million to fully fund the worldwide commercialization of its modular surgical robotics system and said it plans to “imminently” begin rolling out its Versius surgery system, starting in hospitals across Europe and Asia.

Medtronic and Novo Nordisk have agreed to integrate their digital offerings for people with diabetes, including the sharing of data between continuous glucose monitoring devices and smart insulin pens.

Following two joint ventures, AI-based drug designer Atomwise has announced two more projects in quick succession—including one with a Chinese biopharma company it says could net the company up to $1.5 billion for developing first-in-class molecules.

The end goal is to create a “connected device experience” for people managing their diabetes, according to the two companies, through new smart insulin pens, smartphone apps for titration and cloud-based software analytics.

When asked the company's plans for the year ahead—following a splashy debut on the Nasdaq that raised $390 million outright and accelerated over the day—10x Genomics co-founder and CEO Serge Saxonov said, “I tend to think more in terms of decades.”

Pfizer is planning to establish a multinational network of digital research hubs. Starting with a new facility in Thessaloniki, the Big Pharma hopes to develop tech that can be incorporated into its development pipeline of medicines and vaccines.

AI-based drug designer Insilico Medicine has raised $37 million to help commercialize its technology, on the heels of a landmark paper for the company that showed its computer networks were able to generate, synthesize and preclinically validate a series of promising compounds from scratch in less than 50 days.

Apple plans to launch three healthcare studies—conducted through a new research-gathering app—to test how well its Apple Watch can track a person’s cardiovascular health and mobility, changes in their hearing and women’s health and fertility.

Google and the Mayo Clinic have signed a decade-long partnership that aims to transform the healthcare institution’s uses of patient data, artificial intelligence and cloud-computing services, across all its work from care delivery to product development.

Artificial intelligence-based drug designer Atomwise has launched two new joint venture projects—one to test its bespoke molecules in living tumor organoids, and another to develop targeted inhibitors of a protein linked to triple-negative breast cancer.

Former FierceMedTech Fierce 15 winner Axonics Modulation Technologies has received FDA approval for its rechargeable neuromodulation implant to treat bowel dysfunction. According to the company, its r-SNM system has a functional life of 15 years, and is compatible with full-body MRI scans.

A new version of Medtronic’s drug-coated balloon, designed specifically to help reopen the collapsing fistulas used by patients as access ports for dialysis treatments, has met its primary endpoints in its first large study.

Wearable ECG patch maker iRhythm Technologies has begun working with Verily Life Sciences to develop ways to better screen, diagnose and manage patients living with so-called “silent” atrial fibrillation. iRhythm estimates that, of the patients who suffer a stroke due to AFib, about one-in-five were previously unaware of their heart rhythm disorder.

Abbott has begun its first randomized, pivotal trial to test a new method of fixing leaky tricuspid heart valves, where there are currently no approved minimally invasive repair therapies available.

Stryker is snapping up CT scanner manufacturer Mobius Imaging—along with the latter’s sister company focused on spine surgery robotics—in a $500 million deal that bolsters its spine division’s capabilities in image-guided procedures.