InsideTrack briefs: Glucose meters top list of FDA secret device filings

Blood glucose meters and test strips made by the Johnson & Johnson subsidiary LifeScan accounted for the largest number of adverse-event reports that were filed without public disclosure in a U.S. Food and Drug Administration program that has since been closed down.

An initial review of data released June 21 by the FDA showed LifeScan filed 2.3 million secret adverse-event reports regarding its SureStep Flexx glucose meter and related diabetes products intended to be used in hospitals between 2006 and 2018. That was more than 20% of the entire data set. The previously undisclosed FDA data trove included nearly 6 million reports covering more than 100 different products made by dozens of different companies.

The second-highest total was for dental implants and supplies made by Nobel Biocare, a subsidiary of Washington-based conglomerate Danaher Corp. Federal law requires the makers of medical devices to file reports with the FDA in situations where the device caused or may have caused health problems in a patient, or when a device malfunctions in a way likely to happen again.

However, the FDA quietly gave out more than 100 exemptions since 1999, covering between seven events and 2.3 million events each, in situations where the agency said the problems were already well-known. The exemptions allowed manufacturers to file spreadsheets of events through a program known as Alternative Summary Reporting (ASR).

Regarding the devices generating the most reports, an FDA spokesman said in a statement to the Star Tribune: "Both of these products are commonly used medical devices, and therefore it is expected that reported events for those devices would represent a larger portion of the events than those for devices that are not commonly used."

The FDA in 2014 allowed Medtronic to file summaries of more than 1,000 reports of patient harm following the use of its controversial Infuse bone-growth product.

Although the filings were more than five years late, and included four patient deaths, the FDA decided the potential risks described in the reports were already known to the medical community by the time they were submitted.

Tennis star Serena Williams will appear in stores on the classic orange Wheaties box in coming weeks. General Mills said in addition to her status as one of the greatest tennis players of all time, it also chose Williams because of her cultural and social influence.

"Serena exemplifies all of the personal attributes that Wheaties looks for when choosing who its next champion will be," said Tiffani Daniels, marketing manager for Wheaties, in a statement.

Williams has earned 23 Grand Slam singles titles and 14 Grand Slam doubles titles. She's also won four Olympic gold medals. Off the court, Williams is a well-known advocate for gender and racial equality. She's a businesswoman, philanthropist and admired mother-athlete.

"I am so excited to be on the cover of the next Wheaties box," Williams said. "I hope my image on this iconic orange box will inspire the next generation of girls and athletes to dream big."

Kristen Painter

The provider of commercial real estate information services looked at the 50 most populous cities and, using a 13-factor measurement, narrowed the list to 20 cities with Austin, Texas; Washington, D.C., and Seattle ranking first, second and third respectively.

Minneapolis finished between Fort Worth, Texas, and Oakland, Calif., with the blog crediting Minneapolis as one of the hottest startup hubs in the Midwest. A strong millennial population that has grown 13% over the past five years was one of the area's leading factors.

The other factors included: nonemployer growth; startup survival rate; startup density; startup growth rate; Kickstarter success; tech education; tech education growth; tech employment growth; wage growth; rent/income ratio; co-working cost; millennial population percentage and millennial population growth. Each factor was weighted either five or 10 points for a total score of 100.

The list didn't consider other important factors to startup success, such as tax rates and whether the areas have a supportive startup culture and have available mentors from mature companies or other successful startups.

Minneapolis also ranked second among the 20 ranked cities for affordable co-working cost, with co-working rates just 2.4% of the area's median income. Only Austin provided more affordable co-working space. That's thanks, no doubt, to competition from Fueled Collective but also national players like WeWork, Novel and other spaces.