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BioWorld - Monday, June 15, 2026
Home » Topics » Medical devices » Digital health

Digital health
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Nurse holds Ipad with elderly patients

Orexo initiates study combining digital therapy and medication for opioid use disorder

July 16, 2021
By Annette Boyle
Orexo AB enrolled the first patient in a pivotal trial of its digital therapeutic Modia plus sublingual buprenorphine/naloxone for treatment of opioid use disorder (OUD). Orexo’s Zubsolv, the combination of buprenorphine and naloxone used in the study, has been employed to help U.S. patients with OUD since 2013.
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Heartflow software on different devices

Heartflow charts IPO via $2.4B SPAC deal

July 15, 2021
By Meg Bryant
Heartflow Holding Inc. is aiming to bring its noninvasive, artificial intelligence (AI)-based test for coronary heart disease to more doctors and patients via a merger with Longview Acquisition Corp. II. The deal, valued at an enterprise value of about $2.4 billion, is the latest in a steady stream of med techs queueing up to go public via a “blank check” special purpose acquisition company (SPAC) this year.
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Nurse holds Ipad with elderly patients

Orexo initiates study combining digital therapy and medication for opioid use disorder

July 15, 2021
By Annette Boyle
Orexo AB enrolled the first patient in a pivotal trial of its digital therapeutic Modia plus sublingual buprenorphine/naloxone for treatment of opioid use disorder (OUD). Orexo’s Zubsolv, the combination of buprenorphine and naloxone used in the study, has been employed to help U.S. patients with OUD since 2013.
Read More
South Korean flag on building

South Korea pledges $870M for bio data dam, makes progress on regulation

July 15, 2021
By Gina Lee
South Korea plans to create a bio data dam, a step toward generating the necessary industrial ecosystem in the country’s bid to become one of the top seven players in the global medical device market by 2025.
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Telehealth illustration

CMS proposes to extend some U.S. telehealth coverage through the end of 2023

July 14, 2021
By Mark McCarty
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.
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Screen views of Reset-O on smartphones

Data shows Pear’s Reset-O significantly reduces health care utilization in patients with opioid use disorder

July 14, 2021
By Meg Bryant
Pear Therapeutics Inc. released nine-month, real-world data showing long-term reduction in costly health care utilization categories, including inpatient stays and emergency department visits, in patients with opioid use disorder (OUD) who utilize its Reset-O prescription digital therapeutic. The findings suggest that Reset-O could help to stabilize patient outcomes long-term when used in conjunction with outpatient treatment.
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Vocal soundwave illustration

Qualcomm to integrate Sonde One vocal health tracker on mobile device chips

July 13, 2021
By Annette Boyle
Sonde Health struck a deal with Qualcomm Technologies Inc. to embed its vocal health biomarker product, Sonde One, in the Snapdragon 888 and 778G 5G mobile platforms. The deal would make vocal biomarker monitoring native to the devices that use the company’s chips in mobile and IoT devices.
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Pivot breath sensor and app on phone

Carrot tweaks labeling for smoking cessation breathalyzer

July 12, 2021
By Ana Mulero
Looking to increase adoption among more tobacco users, Carrot Inc. expanded the indications for use of its smoking cessation breathalyzer with a new FDA 510(k) clearance to include the claims related to a recent study in the labeling and promotion of the sensor. The clinical trial demonstrated the Bluetooth-enabled sensor’s ability to increase a person’s motivation to quit.
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Regulatory actions for July 12, 2021

July 12, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carrot, Quidel, Ortho Clinical Diagnostics, Uvision360.
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In the clinic for July 12, 2021

July 12, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cognetivity Neurosciences, Geneoscopy, Inotec AMD, Perspectum.
Read More
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