Frank Westermann sold his previous startup, mySugr, to Roche four years ago. Now, he’s starting a new company with the goal of making healthcare providers and diabetes medications more accessible. 

The FDA has approved the first biosimilar that references the blockbuster Roche drug Lucentis. The Biogen and Samsung BioLogics joint venture that developed the biologic product have approval to treat three eye conditions that lead to vision loss.

Along with daily surveys, a research team from Mount Sinai used Apple Watches to measure how stress impacted healthcare workers’ bodies and pinpointed the characteristics that were associated with lower stress levels over time.

A lower-dose version of Pfizer and BioNTech’s Covid-19 vaccine showed safety and efficacy results in children 5 to 11 that were comparable to those in an older age group. With these preliminary data, the companies said they plan to seek emergency use authorization of the shots.

Healthcare brands invest enormous sums of money in marketing campaigns, websites, and apps that will never be effective until a consumer can overcome the data barriers to healthcare access.

INVEST Digital Health kicks off today and runs through September 23. Held in a virtual format due to Covid-19, the healthcare conference brings together innovative investors across the healthcare spectrum, prominent industry players and the most promising digital health startups. Register today!

Bioprocessing technologies company Repligen is acquiring Avitide, and its biologics purifying technology, in a $150 million cash and stock deal. Repligen said Avitide will help it meet growing demand for gene therapy solutions.

The agency has suspended enrollment in three UnitedHealthcare plans and one Anthem plan for 2022 because the plans did not spend enough of their premium incomes on medical benefits and claims. The payers can contest the suspension, though it is unclear if they plan to.

As hospitals and health systems redefine and deliver consumer-oriented care, those that understand the value of the patient experience will emerge as leaders in the post-pandemic healthcare market.

The startup, which has a cleared device to reduce tremors using electrical stimulation, recently shared the results of a post-market analysis showing device use and efficacy. 

An FDA advisory panel voted down a proposal for booster shots of the Pfizer/BioNTech Covid-19 in the general population, opting instead to support third shots in certain high-risk groups, such as the elderly. Panelists want to see more information supporting the need for a booster, as well as data about a heart safety risk the vaccine may pose to young males.

With the results of a recent trial, Abbott is seeking an expanded indication from the FDA for its CardioMEMS device, intended to prevent hospitalizations in patients with heart failure.  It’s also hoping to win over national coverage from CMS. 

The practice, which initially will only be offered to CareFirst BCBS commercial members, provides an array of services, including preventive care, insurance navigation and behavioral and mental health services. Patients will be referred to in-person care with local providers when needed.

Rune Labs developed software that aggregates brain data, providing insights for clinical care and clinical research. Health systems are starting to adopt the technology, and the startup has now raised $22.8 million to grow that part of the business while also expanding use of the technology in drug development.

Check out new developments from HealthMine, Kiiio, Cured, Hinge Health and more.

If the merger is approved, the combined health system will operate 33 hospitals and 385 clinics across six states. The merger also represents the joining together of a faith-based organization, SCL Health, and a secular entity, Intermountain.

A previous investigation by MedCity News found that ElectrifAi was touting an improperly-developed algorithm during the earliest phase of the Covid-19 pandemic, with both the company and CEO defendants in an employment discrimination lawsuit. A year later, lawsuits are piling up as more former employees complain that the company and CEO lied about its AI capabilities and business. 

The company, which offers mental health solutions for employers and health plans, recently closed a $190 million series C round, that included both equity and debt. It also brought on Guardian Life as a strategic investor.

This new type of ransomware — which was linked to a cyberattack against an Ohio-based health system in August — employs a multi-pronged approach, focusing not only on encrypting sensitive data but also on terminating backup processes to make it harder for organizations to recover from the attack.

Takeda Pharmaceutical drug mobocertinib was approved by the FDA to treat non-small cell lung cancer in patients whose tumors carry a rare genetic signature. With the approval, Takeda can offer an oral alternative to a recently approved Johnson & Johnson drug that targets the same mutation but is given as an infusion.