Health

Tasso receives FDA 510(k) for patch home blood collection device



Tasso received FDA 510(k) certification for its patch-type blood collection device, Tasso+.

The device consists of a lancet, attached to the arm, connected to a test tube for collection. After the user rubs their arm or uses a thermos bag and sanitizes the test site, they press a button on the front of the device to initiate capillary aspiration. The tube can then be removed and sent to a laboratory for analysis.

According to Tasso, it usually takes 10 to 15 minutes to complete the test. The newly cleared Tasso+ will be on the market in the fourth quarter of this year.

The company said Clearance will allow pharmaceutical companies to use the device for decentralized clinical trials, while healthcare systems and physicians can use the device for patient care.

Ben Casavant, CEO and co-founder of Tasso, said: “With the industry’s continued interest in decentralized clinical trials and diverse experimental applications, there is a need for solutions. Our convenient, virtually painless, high-quality blood collection method is at an all-time high,” said Ben Casavant, CEO and co-founder of Tasso, in a statement. .

“This FDA Class II medical device licensing will help improve patient care by clearing the bottlenecks associated with traditional phlebotomy and allowing more individuals to obtain tests. They need it when they need it. We’re excited to usher in a new wave of major commercial opportunities for the company and lead the industry in the future of remote testing.”

TREND TO BIGGER

Tasso was founded about a decade ago by co-founders Casavant and Erwin Berthier, who serve as chief technology officer. The company has annealed in the Cedars-Sinai Tech Stars . accelerator in 2017 and two years later increased $6.1 million Series A.

The startup scored another point 17 million dollars in 2020followed by a huge number 100 million USD round of RED Series last year.

Tasso has two other blood collection devices, which have not yet been approved by the FDA 510(k). Tasso-M20 provides dried blood samples, while Tasso-SST provides anticoagulant-free prepared blood samples.

Other companies that aim to bring more lab tests into the home include Everlywell, Cue Health and the recent Labcorp traditional player cooperation with Getlabs to provide home sample collection. The giant of Telehealth, Teladoc also recently Expanded into a home collection for its primary care program through a partnership with Scarlet Health.

Since the COVID-19 pandemic, decentralized clinical trials have also gain traction. DCT Medable Platform, Elevated $304 million in EASY Series funding last year, announced a partnership with CVS and connected device company Withings This year.

Others offering DCT technology include uMotif, Curebase and Improve health.



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