FDA OKs Abbott’s New Pacemaker

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Over a million patients worldwide get a new pacemaker every year. The vast majority of those pacemakers require surgery to be implanted and use electric wires that connect to the heart known as “leads.” The next generation of the technology, known as “leadless” pacemakers, don’t require surgery and are injected using a catheter into a vein, but so far have only worked in a single chamber of the heart. Today the FDA approved Abbott’s leadless pacemaker, the Aveir VR, for both chambers of the heart.

This was a substantial technical feat. Abbott’s proprietary system works by transmitting high frequency electric pulses that take advantage of the electric conductivity of blood to deliver the signal. In a clinical trial, over 97% of the patients had both chambers of their heart beating normally after three months. Read more from Forbes senior editor Alex Knapp here.

The MedTech Billionaire Waging A Patent War With Apple

Joe Kiani, the founder and CEO of Masimo, has spent $60 million fighting the nearly $3 trillion company in court over the Apple Watch, but he’s also facing a boardroom battle over his own consumer tech push. These legal fights are coming as Kiani, who Forbes estimates is worth $1.2 billion, is starting to enter the consumer space with watches and other wearables. Next up in the multifront legal battle is an International Trade Commission decision on whether to ban certain Apple Watch imports, which is expected by July 17.

Pipeline & Deal Updates

Wound Care: Cresilon, a Brooklyn, New York-based biotech startup that has developed a plant-based gel to stop bleeding, has received clearance from the FDA for human use in minor cuts and lacerations. Previously, the product had been approved for veterinary use. Cresilon CEO Joe Landolina was on the 2023 Forbes Under 30 Healthcare list.

Preventative Care: Neko Health, a Stockholm, Sweden-based startup cofounded by Spotify CEO Daniel Ek, has raised a $65 million Series A round to expand its medical scanning technology throughout Europe. The company says the 10-minute scans, which cost $270 are currently only offered in Stockholm, can help doctors detect skin cancer and cardiovascular disease earlier, among other health issues.

Brain Disorders: Carthera, a Paris-based startup spun out from Sorbonne University, has raised a $40 million Series B round as it launches a phase 3 clinical trial of its ultrasound-based device that opens the blood brain barrier to administer chemotherapy for patients with the brain cancer glioblastoma.

This Psychologist Got Rich Selling Her Chain Of Autism Treatment Centers. Now She’s Trying To Buy It Back

Doreen Granpeesheh built the Center for Autism and Related Disorders into a national chain and sold it to private equity firm Blackstone in a $600 million deal. Now, in an unexpected twist, she is trying to buy the bankrupt company for a much smaller sum.

Other Healthcare News

Rite Aid reported a quarterly loss of more than $306 million and the drugstore chain is closing 25 stores.

The North Carolina legislature approved a bill that restricts access to gender-affirming care for minors.

The U.K. agency that assesses which drugs are offered through the country’s public health system says “more evidence” is needed for Eli Lilly’s diabetes and weight loss drug Mounjaro.

Australia’s medical regulator has approved psilocybin and MDMA for therapeutic use as of July 1.

Reuters reported that aspartame, one of the most widely used artificial sweeteners, will be classified as a possible carcinogen by the World Health Organization in July. Here’s an overview of where the research stands.