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Digital health funding continues its record-breaking streak with a whopping $21.3bn raised in the first three quarters of this year, breaking the 2020 full-year record of $14.bn, according to a new report from venture capital firm Rock Health.

Third-quarter funding was down slightly from the second quarter with $6.7bn secured across 169 deals compared to $8.2bn raised in the second quarter of 2021.

The top five funded clinical indications in the first three quarters of this year are mental health ($3.1bn), cardiovascular disease ($1.4bn), diabetes ($1.4bn), primary care ($1.4bn), oncology ($1.2bn) and substance use disorder ($793m), Rock Health reported.

In the diabetes space, Israeli-based Hagar NIG announced in August, it raised $11.7m in a series B funding round, following a $4.4m series A round in March. Hagar said it will use the new funding to conduct clinical trials to support US Food and Drug Administration clearance for its GWave non-invasive continuous glucose monitoring (CGM) technology. The company plans to put its CGM technology in a smartwatch and eventually sell it to a larger medtech player. (Hagar Lands Funding To Develop Noninvasive Glucose Monitoring Watch)

Among notable deals, Akili Interactive Labs, which developed the FDA-cleared video game-based therapy for children with attention-deficit/hyperactivity disorder (ADHD) EndeavorRx, announced a licensing deal with Tali Health. Under the agreement, Tali Health will license its gaming technology, designed to assess and improve attention in children three to eight years old, to Akili for $37.5 in future milestone payments plus royalties and potential revenue. (Akili Pays 375M To License Talis Tech For Early Childhood Attention Impairments)

In September, Flywheel.io, a platform that helps researchers process imaging data, used $22m from a series C funding to acquire St. Louis-based Radiologics, a competing medical processor. Last month, Zoll Medical Corporation announced plans to acquire Itamar Medical Ltd. for a total value of $538m, adding Itamar’s home-based testing for sleep apnea to Zoll’s cardiopulmonary product offering. (Zoll Medical Signs Definite Agreement To Buy Itamar Medical For $538M)

AAOS 2021

The American Academy of Orthopedic Surgeons held its annual meeting from 31 August through 4 September in San Diego and Medtech Insight took the opportunity to meet with company executives to report the news.

Think Surgical demonstrated its newly launched TSolution One Total Knee Application, which is the only active, open-implant robot system for total knee replacement on the US market today. (AAOS 2021 A Closer Look At Think Surgicals Active OpenImplant Orthopedic Robot And Whats Ahead)

Zimmer Biomet Holdings, Inc. and its partner Canary Medical announced on 30 August that the FDA cleared a de novo application for their Persona IQ implant, the first implantable smart device for total knee replacement that uses sensor-based technology to provide real-world post-surgical patient data for the care team and patients. (Zimmer Biomet Canary Medical Win FDA De Novo For First Smart Knee Implant)

Joseph Bosco, an orthopedic surgeon at NYU Longone Health talked to Medtech Insight before the conference about hot button issues in the orthopedic community and what to expect in the future. (Exec Chat AAOS 2021 Outgoing President Bosco Discusses HotButton Issues InpatientOnly List PreAuthorization New Tech)

He agreed that robotic-assisted systems will be common in the future, driven by smaller, easy-to-use, intelligent robotic systems applied to a wide range of procedures.

Advances in artificial intelligence, machine learning and sensor technologies are also expected to drive the autonomy of robotic surgery systems. The third part of a three-part Market Intel series on the future of surgery highlights pros and cons of robotic-assisted systems with key perspectives from orthopedic surgeons and industry experts. (Market Intel Robotic Surgery Holds Great Promise But Is Not Quite There Yet)

On The Regulatory Front

There also have been a number of regulatory developments in digital health over the past month.

The FDA published a new website that tracks the artificial intelligence/machine learning products it has reviewed and allowed on the market. (New FDA Web Page Spotlights AIML Progress)

In August, the Medical Device Innovation Consortium (MDIC) launched a Digital Health Initiative to work on issues related to digital health regulations. If fruitful, it could be key to helping develop the FDA’s pre-certification (pre-cert) program, which would create a faster path to market for certain digital health products. (MDIC Digital Health Initiative Could Be Crucial To FDA Pre-Cert Program)

In September, the agency cleared two de novo authorizations. (FDA Greenlights First-Of-Its-Kind Heart Software)

It cleared FEops HEARTguide, which is meant to simulate how a heart transplant will perform inside a patient and Paige.AI.’s Paige Prostate medical software to aid pathologists in finding prostate cancer. (Another Set Of Eyes US FDA Authorizes AI Software To Spot Prostate Cancer)

Medtech Insight recently spoke to Cognoa, Inc.’s chief medical officer Sharief Taraman about the future of digital health and artificial intelligence and machine learning in particular. Taraman said the technology offers great opportunities to help increase patient access to treatments and ease physician workload, but could also exacerbate health care disparities already in the health care system.

He advised companies to be cognizant of potential biases and adjust for them when developing their products. (Expert AIML Pediatric Software Brings Hope But Also Potential To Magnifying Disparities)

Noteworthy

The FDA is holding a virtual public workshop on 14 October to discuss transparency of AI/ML medical devices. (FDA Panel Meeting To Focus On AIML Device Labeling Transparency)

In September, Congress issued a bipartisan resolution creating the first “Telehealth Awareness Week,” (19-25 September), recognizing telehealth’s growing support and appeal.

Telehealth Awareness Week (19-25 September) is sponsored by the DC nonprofit American Telemedicine Association to highlight the increasingly critical role of digital health, especially during the pandemic, and for patients in remote areas and with difficulty traveling. ()

Other noteworthy stories in our Digital Health Roundup;

Read also

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