Speakers at AdvaMed’s Virtual MedTech Conference did not shy away from the subject of racial injustice, and at least one CEO encouraged his peers to “stand up for what is right.” The conference also addressed health disparities and diversity needs within the industry itself. AdvaMed also incorporated diversity topics into the program in a variety of ways, including a podcast featuring Kwame Ulmer, a FDA veteran and founder of MedTech Color. Recently, Boston Scientific unveiled its plan to take on systemic racism in healthcare through its Close the Gap initiative.
FDA Commissioner Stephen Hahn told AdvaMed’s President and CEO Scott Whitaker during the Virtual Medtech Conference that FDA’s scientists have made decisions about medical products throughout the pandemic and will continue to do so. Hahn became commissioner in December 2019, shortly before the COVID-19 outbreak spread to the United States and was declared a global pandemic. AdvaMed CEO Scott Whitaker asked Hahn about FDA’s vaccine approval process, pointing out that “some people are raising questions and skepticism about whether career scientists are still in charge.” Hahn sought to shoot down that skepticism. “Let me just be clear up front—our career scientists throughout this pandemic have made decisions about medical products and will continue to make those decisions,” he said.
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The rumors are indeed true – Illumina is attempting to acquire early cancer detection specialist Grail for about $8 billion. Grail was spun off from Illumina in 2016. The proposed acquisition comes hot on the heels of Grail announcing it was seeking to go public.
An investigation by EU antitrust regulators concerning Google’s pending acquisition of Fitbit has been extended to Dec. 23, according to a report from Reuters. Regulators began a probe into the deal in August. The main concern from regulators seems to be the amount of data Google would have access to if the deal were to come to pass.
Boston Scientific has signed an investment agreement and an exclusive option to acquire Farapulse, the developer of the pulsed-field ablation (PFA) system. The move has the potential to strengthen the Marlborough, MA-based company’s position in the treatment of atrial fibrillation. Farapulse received breakthrough designation for the PFA system last year. The device – comprising a sheath, generator, and catheters – is intended to ablate heart tissue via the creation of a therapeutic electric field instead of using thermal energy sources such as radiofrequency ablation or cryoablation.
As speculated, blood oxygen (SpO2) tracking will be enabled on the Apple Watch Series 6. The sensor uses infrared lights to measure your blood oxygen in seconds, and can take measurements while you sleep. The company is working with various research teams to examine how longitudinal measurements of blood oxygen and other physiological signals can help manage and control asthma; how blood oxygen measurements and other Apple Watch metrics can help with management of heart failure; and how Apple Watch apps such as heart rate and blood oxygen could serve as early signs of respiratory conditions like influenza and COVID-19.
Speaking of Apple ...
Fitbit’s ECG app is slated to be available in October. The product winning a nod in both the United States and Europe comes about two years after Apple's FDA nod for an ECG app. It also comes at a time when Fitbit is in the middle of being acquired by Google.
Illumina could be interested in (re-)acquiring liquid biopsy startup Grail, according to a recent report from Bloomberg. The gene sequencing company could pay more than $8 billion for Grail which now has a valuation of $6 billion, Bloomberg reported citing people familiar with the matter. The rumored deal comes about a week after Grail's IPO news (see below), and about four years after Illumina spun Grail off into a separate company.
Liquid biopsy specialist Grail is set to go public four years after it was spun out from Illumina. The Menlo Park, CA-based company is developing early cancer detection tests and has set a placeholder amount of $100 million for its IPO. The company is known for its exorbitant financings and has thus far brought in about $1.9 billion in venture capital funding.
Users of NeuroMetrix’s Quell wearable pain-relief device could be eligible for payments from the Federal Trade Commission (FTC) by check or through PayPal. FTC recently announced it was refunding almost $3.9 million to purchasers of the Waltham, MA-based company’s device that was designed to treat chronic pain throughout the body when placed below-the-knee. In a release, FTC said NeuroMetrix and its CEO, Shai Gozani, sold Quell to consumers, touting it as “clinically proven” and “FDA cleared” for widespread chronic pain relief. However, the agency said the defendants lack scientific evidence to support widespread chronic pain-relief claims, and their claims about clinical proof and the scope of FDA clearance for this use are false.
Nobody can accuse Chembio Diagnostics of giving up too easily. FDA revoked the emergency use authorization (EUA) for Chembio Diagnostics' first antibody test. Now the company seeks an EUA for a new rapid COVID-19 antibody testing system. The company said new performance criteria from FDA regarding COVID-19 antibody testing provided clarity and direction for its development objectives.