Software-as-a-medical device (SaMD) came into its own during the pandemic as digital health applications enabled patients to receive care from home through telemedicine, apps and remote patient monitoring. At the 2021 Medtech Conference, a panel of regulators, advocates and digital health executives discussed how the last 18 months may permanently change the regulation of these devices, the steps manufacturers can take to secure the footholds they gained, and how the U.S. CMS can enable digital health to achieve its promise.

Health-tech startup Doctor Anywhere Ltd. (DA) has raised $88 million in series C fundraising, as the telehealth sector continues to be attractive for investors. The round is one of the largest private investments ever raised by a Southeast Asian digital health company and was led by growth equity investor Asia Partners. Novo Holdings, Philips, OSK-SBI Venture Partners, EDBI, Square Peg, IHH Healthcare, Kamet Capital and Pavilion Capital also participated.

Opya Inc., a provider of integrated autism services, secured $15.4 million in a series A fundraising round. New investors in the round included Panoramic Ventures, Softbank’s Opportunity Fund, Disability Opportunity Fund, and Raven One Ventures. Divergent Investments and Altitude Ventures added to their existing investments in the company.

The frequent calls for an expansion of telemedicine have come with relatively hushed advisories about the potential for fraud, concerns that have been borne out by an indictment recently returned by a federal grand jury in New Jersey. A company that presented itself as a provider of telemedicine services has been charged with filing $784 million in false claims for unnecessary durable medical equipment.

Medicare coverage of telehealth services in the U.S. received a boost during the COVID-19 pandemic, a change that stakeholders have argued should be made permanent. The Centers for Medicare & Medicaid Services (CMS) has proposed to extend coverage of some of these services throughout calendar year 2023 in the draft Medicare physician fee schedule, but some stakeholders are urging Congress to act before the end of the year to make these benefits permanent.

It’s not unusual for women to have some uterine contractions during pregnancy. Many of these go unnoticed, but others can be strong and feel like labor. Distinguishing between normal contractions and those that are not can help ensure women at risk of preterm labor get the extra medical care they need. To that end, Tel Aviv-based Nuvo Group Ltd. has launched an FDA-cleared uterine activity (UA) module on its Invu remote monitoring platform.

The latest report by the Medicare Payment Advisory Commission (MedPAC) includes an advisory about unfettered expansion of telehealth, but the commission also said that expanded access to ambulatory surgical centers could trim per-procedure spending, which in some instances is about half the fee paid for a given procedure when performed in a hospital outpatient department (HOPD).

The Biden administration’s fiscal 2022 budget proposal included an allocation for an office described as the Advanced Research Projects Agency – Health, or ARPA-H, which would receive $6.5 billion as part of the National Institutes of Health.

COVID-19 has caused a surge in telemedicine, increasing access to health care without having to physically visit a doctor. In similar ways, it is changing things in the operating room, where advanced technology platforms enable surgeons and specialists to observe or weigh in on surgeries and allow manufacturer reps to assist in procedures using new devices.