Fierce Medical Devices

Less than two months after stepping down as the FDA commissioner, Scott Gottlieb has slipped right back into his old ways, becoming "special partner" at his old life science venture capital firm New Enterprise Associates.

Google’s artificial intelligence development has reached a milestone in lung cancer imaging and prediction, with a CT scan model being able to diagnose cases as well as or better than a group of six radiologists.

Using an innovative wearable, Spire Health has launched a study to develop new digital biomarkers that can predict exacerbations—and potentially hospitalizations—in patients with severe chronic obstructive pulmonary disease.

Novartis, Otsuka, Pfizer and Sanofi have signed onto Verily’s Project Baseline, a program aimed at mapping out a baseline for human health.

Ocular Therapeutix’s drug-eluting insert to treat glaucoma—a small, resorbable hydrogel plug that sits within the tear duct designed to replace 90 days’ worth of daily eye drops—fell just short of meeting the primary endpoint of its first pivotal phase 3 trial.

The once-straightforward definition of a medical device has begun to stretch. And for that matter, so has the definition of a medical devices company. But 2018’s top FDA green lights made one thing clear: The devices most likely to change a patient's life were designed to change their routines the least.

J&J was ordered by a Philadelphia jury to pay $80 million to a woman whose vaginal mesh eroded, on the heels of a $120 million verdict issued against the company's Ethicon unit last month.

Schrödinger has raised more money, bringing the total size of its recent haul up to $110 million. The computing-enabled R&D shop will use the money to advance its nascent pipeline of wholly owned drugs.

Arrhythmia-focused Acutus Medical is moving to acquire catheter developer Rhythm Xience while launching a handful of new strategic partnerships as it looks to expand its portfolio beyond its heart mapping and visualization platform.

The FDA is warning patients with diabetes against using homegrown treatment devices such as combinations of glucose monitoring systems, insulin pumps or dosing systems that are not recognized by the agency.

The FBI has launched its own investigation into a handful of the world’s largest medtech companies, stemming from claims of illegal kickbacks being paid to Brazilian government officials over the past 20 years—in return for contracts through the country’s public health programs that administer over 210 million people, according to a report from Reuters.

Johnson & Johnson’s electrophysiology-focused Biosense Webster division, makers of heart-mapping hardware and ablation catheters to treat cardiac arrhythmias, has launched a new cloud-based network to link up the field’s myriad devices and share the data used in practice.

Abbott has signed on to the wide-ranging neuroscience project run by the National Institutes of Health, pledging to provide its neuromodulation tech for the public-private research effort.

Ginkgo Bioworks is buying Warp Drive Bio’s genome mining team, tech and database, eyeing the platform for use in next-generation antibiotics.

A group of European researchers and Thermo Fisher Scientific found that next-generation sequencing-based blood tests were able to detect and monitor the progressively changing genetics of lung tumors—illustrating developments in drug resistance over time, while showing results comparable to tissue biopsies.

ArcherDX has closed on a $60 million financing round to support its companion diagnostic program spanning solid and blood tumors as well as circulating tumor DNA tests.

Grail’s multicancer blood test has taken a helpful step closer to approval, by obtaining a breakthrough device designation from the FDA.

Zebra Medical Vision has received a go-ahead from the FDA to use artificial intelligence to quickly scour X-rays and alert clinicians for signs of pneumothorax, the potentially fatal buildup of air between the lung and the chest wall.

While other on-the-go electrocardiograms may only observe the heart’s electrical signals from a single angle, AliveCor has moved ahead to secure an FDA clearance for its personal device offering six leads, providing more detailed views into heartbeats and arrhythmias.

Pulmonx, maker of an airway valve implant for patients with serious lung disease, has secured $65 million in new equity financing for its global commercialization efforts through an oversubscribed round led by the Hong Kong-based Ally Bridge Group.