Medtech in a Minute: A Huge Step for Medtronic's Hugo, and More

Medtronic Hits a Huge Hugo Milestone

Medtronic has hit another milestone for its Hugo robotic-assisted surgery system. The company has enrolled the first patient in the Expand URO US clinical trial. The robotic-assisted prostatectomy procedure was performed by Michael R. Abern, MD, at Duke University Hospital in Durham, NC, who called it "an exciting moment" as the technology provides many benefits within his specialty of urology. The prospective, multi-center, single-arm trial will evaluate the safety and performance of Hugo for urologic procedures, which are one of the most commonly performed procedures using robotic-assisted surgery. Medtronic intends to use the Hugo in the study for urologic procedures including radical prostatectomy, radical cystectomy, and nephrectomy (partial or radical procedures). The U.S. trial follows an FDA investigational device exemption and will enroll up to 122 patients at six sites across the country.

Rumor Has It, Medtronic Spin-Offs Are a Hot Commodity

The latest medtech rumor suggests Siemens Healthineers and GE Healthcare are both interested in businesses Medtronic is in the process of spinning into a new company. Medtronic revealed plans in October to spin its patient monitoring and respiratory interventions businesses into a new company. Combined, these businesses generated about $2.2 billion last fiscal year, representing about 7% of total Medtronic revenue. Those spin-off plans could turn into a sale instead, however, according to recent news reports citing "people close to the matter." The reports suggest that Medtronic is open to a potential sale and the businesses could be valued at more than $7 billion.

M&A Picks Up Steam After a Slow 2022

Merger and acquisition (M&A) activity has been sluggish through most of 2022, but appears to be picking up steam as the year comes to a close. One recent example is Tandem Diabetes Care's announcement that it is acquiring AMF, the company that developed the Sigi Patch Pump. While M&A activity has been slow in 2022, the year has been quite busy otherwise for companies in the diabetes tech space.

And in case you missed our last Medtech in a Minute report...

A Long-Serving Medtech CEO Announces Retirement

After more than two decades at the helm of Edwards Lifesciences, CEO Michael Mussallem will retire in May 2023. Mussallem has served as the company's CEO since it spun off from Baxter and became a publicly traded company in 2000. Last week, MD+DI recalled the Most Memorable Moments for Edwards Lifesciences Under Mussalllem.

Not So Sunny in San Jose Last Week for Balwani

Ramesh "Sunny" Balwani has been sentenced to 12.9 years in prison and three years on probation for his role in the Theranos fraud. The former Theranos executive is expected to surrender to prison on March 15. The amount of restitution he will have to pay will be determined in a separate hearing. Meanwhile, Elizabeth Holmes has asked to stay out of prison pending an appeal of her conviction and 11.25-year sentence. Holmes confirmed last week night via a legal filing that she is pregnant with her second child. Legal experts say Holmes' appeal process could take years.

Apple Scores a Juicy Victory Over AliveCor

A U.S. Patent and Trademark Office tribunal issued out a ruling that noted three patents owned by AliveCor were invalid. The ruling helps bolster Apple's defense in a potential import ban on the Apple Watch in a separate but related dispute.

Its 'Better Late Than Never' for Dexcom G7

After multiple delays, FDA has cleared the Dexcom G7 continuous glucose monitoring device. The much-anticipated regulatory milestone comes nine months after the same device won a CE mark for marketing in the European Union.