Or maybe it is. After all, stopping snoring has paid off pretty nicely for the San Diego-based sleep apnea device company, which has a more than 40% share in the growing market for products to diagnose, treat and manage respiratory disorders.
When John Kornberg joined then-BioDrain Medical in 2011 as an investor, the company had spent the past decade developing its Streamway surgical waste management device and getting clearance to commercialize it in the U.S. But, Kornberg told MassDevice.com recently, it was quickly apparent that BioDrain was stalled, unable to leverage its 510(k) clearance from the FDA into significant U.S. sales.
Renal denervation is still in its youth, but the limited clinical trials and lack of substantial confirmation hasn’t curbed much of the hype for the technology as a means of treating patients with resistant hypertension.
Most people are brought into the medical device industry because of a passion for a specific disease or a personal connection to a condition that’s had an impact on his or her life.
For Jim Peterson, the CEO and founder of CeQur, that motivation was right inside his own house. His daughter was diagnosed with Type I diabetes at 3 years old.
The FDA has made medical device cybersecurity a high priority, even as it stresses that there have been no reported incidents of malicious medical device hacks or of patients harmed by a security-related issue.
Of the 10.5 million cases of abdominal pain that present in American emergency rooms each year, only about 300,000 end up being confirmed as appendicitis. That means an expensive glut of ultimately unnecessary – and potentially cancer-causing – CT scans performed in ERs.
Regulators and healthcare providers are developing tools and standards to assess medical devices and their digital defenses, as medtech cybersecurity takes some giant steps from the theoretical to the practical.
James Mazzo has put 35 years into the optics and ophthalmology business, so it was no surprise that he got involved with AcuFocus and its device for treating presbyopia. Mazzo, who stepped down from leading Abbott Medical Optics earlier this year, added another title to his resume that’s more of a departure: He’s the 1st "operating partner" at Versant Ventures.