Short seller calls out Clover Health. Hindenburg Research, a short seller that describes itself as a specialist in forensic financial research, published a report criticizing Clover Health's business and alleging that the Medicare Advantage insurtech company has not disclosed active investigations by the Department of Justice.

Hindenburg – which said that it does not have positions for or against Clover – criticized the company and stakeholding venture capitalist Chamath Palihapitiya's hyperbolic conduct during the run-up to its SPAC.

It argued that many of their claims were misleading or outright false, based on interviews the short seller conducted with former employees, competitors, doctors using Clover's software and other sources, such as government reports and insurance filings.

Per the report, Clover is actively under investigation for "at least 12 issues ranging from kickbacks to marketing practices to undisclosed third-party deals" that have not been made public. It also cites multiple former employees alleging that approximately two-thirds of the company's sales "are fueled by a major undisclosed relationship between Clover and an outside brokerage firm controlled by Clover’s head of sales."

Since the report went live this morning, Clover's shares have fallen about 11%, as of the time of publication. Clover has told news publications that it will be issuing a statement responding to the report sometime today.

High in fat, low in data privacy. Elektra Labs, a startup that seeks to track and curate connected health technologies through a catalogue-like digital platform, announced this week that it has partnered with Carnegie Mellon University researchers to develop and standardize a "tech nutrition label" for connected health sensors.

The idea is that these products would each be given a label similar to those required for food products, but instead would focus on how the sensor handles data rights and security, how it has been verified or validated, the price, and general usability in regard to battery life or waterproof ratings, Dena Mendelsohn, director of health policy and data governance at Elektra Labs, said in a blog post. This project would begin with Elektra's existing catalogue of more than a thousand biosensors and, as such, will take time to implement and update, she wrote.

"People must be able to make informed decisions when it comes to technologies that interface with their health data," Yuvraj Agarwal, an associate professor of computer science affiliated with Carnagie Mellon's CyLab and Institute for Software Research, who served as a faculty advisor to the research team, said in a statement.

"We believe that IoT privacy and security labels can be very effective in empowering consumers to make more informed decisions by providing transparency about product manufacturers' stated practices."

FDA asks for more info on Nanox's 510(k). "Digital X-ray" startup Nanox filed a document with the SEC this week that said it has received additional information requests from the FDA regarding the ongoing 510(k) submission for its single-source Nanox.ARC product. These requests require Nanox "to address certain deficiencies and questions, including requests that the Company provide additional support regarding the intended use of the Nanox.ARC and the comparability of the Nanox.ARC to the predicate device," according to the filing.

Nanox said that it plans to respond quickly to the FDA's requests, and expects to submit an additional 510(k) before the end of the year for its multiple-source Nanox.ARC and accompanying Nanox.CLOUD. Assuming FDA clearance, Nanox said it's aiming for an initial 1,000 system shipments by the end of Q1 2022.

ECG for hire. Belfast-based biometrics company B-Secur has received a 510(k) clearance for its HeartKey software library, a set of ECG algorithms that are available for integration with semiconductors across a range of wellness or health-monitoring devices. Per the company's announcement, the software combines user identification with the ability to detect signal conditioning, heart rate and analysis of multiple arrhythmias. That health signal analysis that can be run either on the device itself, within an application layer, or on a cloud network, the company said.

“HeartKey has been developed to enable scalability of medical grade EKG/ECG across IoT devices, and the award of FDA clearance is testament to HeartKey’s performance and the very talented team behind it,” Adrian Condon, CTO at B-Secur, said in a statement. “This clearance should significantly aid our partners and customers [to] increase the speed to market for their technology.”