dermasensor Archives - Medical Design Sourcing

FDA clears DermaSensor AI-powered skin cancer detection device

[Image courtesy of DermaSensor]DermaSensor announced today that the FDA cleared its real-time, non-invasive, AI-powered skin cancer evaluation system.

Miami-based DermaSensor develops a handheld device that uses ESS, a form of optical spectroscopy. It takes noninvasive samples of tissue, capturing cellular-level information. The technology uses hundreds of wavelengths of light in a manner similar to how sonar uses sound.

DermaSensor says physicians can use its AI-powered spectroscopy technology to non-invasively evaluate lesions. They can look at cellular and subcellular characteristics of a lesion in question for skin cancer. The wireless device then provides an immediate, objective result using an FDA-cleared algorithm.

A pivotal study of more than 1,000 patients found 96% sensitivity with the device across 224 skin cancers. When the device produced a negative result, it meant a 97% chance of being benign for all skin cancers. DermaSensor said its device …

DermaSensor reports positive results for skin cancer detection device across multiple skin tones

The DermaSensor device demonstrated its potential to help detect skin cancers across various skin types. [Image courtesy of DermaSensor]DermaSensor today announced promising results from a sub-analysis study focusing on skin cancer detection across different skin tones.

The sub-analysis came from the company’s DERM-SUCCESS study, which previously demonstrated positive results. It focused on the company’s handheld elastic scattering spectroscopy (ESS) device performance across Fitzpatrick skin types. This skin tone scale classifies skin coloring and response to ultraviolet radiation.

Miami, Florida-based DermaSensor’s handheld device uses ESS, a form of optical spectroscopy. It takes noninvasive samples of tissue, capturing cellular-level information. The technology uses hundreds of wavelengths of light in a manner similar to how sonar uses sound.

In the study, DermaSensor’s ESS device demonstrated high sensitivity — 96% — in detecting all …

Data supports DermaSensor skin cancer detection device

[Image from DermaSensor]DermaSensor announced clinical data validating its handheld, non-invasive device for assisting in the detection of skin cancer.

In collaboration with Mayo Clinic and the University of Connecticut School of Medicine, the company presented two studies. One demonstrated the standalone performance of DermaSensor’s novel elastic scattering spectroscopy (ESS) device. The other evaluated the impact of the device on primary care physicians’ (PCP) management of skin cancer.

DermaSensor previously announced positive data supporting its technology in March.

Miami, Florida-based DermaSensor’s handheld device uses ESS, a form of optical spectroscopy. It takes noninvasive samples of tissue, capturing cellular-level information. The technology uses hundreds of wavelengths of light in a manner similar to how sonar uses sound.

“These two pivotal studies, which are two of four studies currently under review by FDA, have shown …

Studies back skin cancer detection device from DermaSensor

[Image from DermaSensor]DermaSensor today presented data from two clinical studies supporting its non-invasive device for evaluating suspicious skin lesions.

Miami, Florida-based DermaSensor’s handheld device uses a form of optical spectroscopy called elastic scattering spectroscopy (ESS). It takes noninvasive samples of tissue, capturing cellular-level information. The technology uses hundreds of wavelengths of light in a manner similar to how sonar uses sound.

DermaSensor’s device received FDA breakthrough device designation and is currently under review by the agency.

Pooled analysis came from the DERM-ASSESS III and DERM-SUCCESS clinical studies. DermaSensor presented results at the American Academy of Dermatology (AAD) 2023 Annual Meeting.

Data demonstrated 94% sensitivity for correctly classifying 338 high-risk lesions and 23% specificity for correctly classifying 1,681 low-risk lesions. All lesions were biopsied by physicians under suspi…

29 cutting-edge medtech innovations recognized with Edison Awards

More than two dozen medical technology developers are winners of the 2023 Edison Awards.

The 29 medtech winners include products from Boston Scientific, Shockwave Medical, Thermo Fisher, DermaSensor and Endiatx. They span four categories: engineering and robotics; health, medical and biotech; manufacturing and logistics; and personal technology and gadgets. Subcategories include smart wearables, noninvasive medtech, advanced drug delivery, AI-assisted medicine, operating room integration and more.

The winners are all finalists for gold, silver and bronze awards. Those awards will be revealed at the Edison Awards Gala on April 20, 2023, in Fort Myers, Florida.

Endiatx co-founder and CEO Torrey Smith with PillBot [Photo by Hardy Wilson for MDO]

Special honors went to Endiatx, which stands by itself as a “game changer” among the approximately 150 Edison Awards winners. Medical Design &…

DermaSensor appoints trio of new executives

[Image from DermaSensor]Skin cancer detection technology developer DermaSensor announced that it appointed three new members to its leadership team.

Miami-based DermaSensor named Larry Anderson as its new chief commercial officer. Dr. Vivien Nguyen also joins as director of medical affairs, while the company promoted Ryan Freiden to COO.

Anderson previously served as VP of sales for Acessa Health, which Hologic acquired. He also held roles at Ethicon, Interlace Medical, Hologic and BG Medical.

“It gives me great pleasure to introduce Larry Anderson as our chief commercial officer,” DermaSensor CEO Cody Simmons said in a news release. “Larry has extensive commercial experience in the medical device field with a strong track record of successfully building teams and launching new technologies.”

Nguyen joins with nearly a decade of experience in medical devices and pharmaceuticals. She held roles at Incyte, Novartis, Suneva Medical and…

They said it at DeviceTalks Boston

Proximie CEO Nadine Hachach-Haram [Photo courtesy of Proximie]

Medtech insiders convened at DeviceTalks Boston 2022 in May to discuss device design, innovation and trends shaping the industry now and in the years and decades ahead.

Here are some of the most quotable insights from panelists and speakers at our live event.

And make sure to save the date — and save your seat — for DeviceTalks West in Santa Clara, California on Oct. 19 and 20.

Read on to hear what medtech leaders had to say at DeviceTalks Boston 2022.

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DermaSensor raises $10M as it braces for U.S. launch

[Image from DermaSensor]DermaSensor announced today that it raised an additional $10 million as it prepares for a commercial launch in the U.S.

Miami, Florida-based DermaSensor’s $10 million fundraising accompanies news that the company met all primary endpoints for two FDA pivotal studies, setting it up to potentially offer the only FDA-cleared, automated skin cancer detection tool on the market that uses any kind of imaging or optical technology.

The DermaSensor device received FDA breakthrough device designation in 2021, and the company expects it to become the first device cleared by the FDA to assist PCPs in evaluating skin cancer.

According to a news release, the device uses a form of optical spectroscopy (called elastic scattering spectroscopy, or ESS) to take non-invasive samples of tissue, capturing cellular-level information from the skin lesion using hundreds of wavelengths of light in a manner similar to how sonar uses sound.

It pro…

DermaSensor wins MedTech Innovator Mid-Stage Companies Pitch Event

DermaSensor can evaluate a skin lesion for skin cancer risk in under 30 seconds, according to the company. [Image courtesy of DermaSensor]DermaSensor — the creator of a handheld, point-and-click device to quickly assess skin lesions for cancer risk — is the winner of the MedTech Innovator Mid-Stage Companies Pitch Event.

The Miami-based mid-stage company beat out 1,000 applicants, more than 20 of which competed on-site May 10–11, 2022 at DeviceTalks Boston. DermaSensor walked away with a cash prize and admission to MedTech Innovator and its host of benefits.

DermaSensor’s device uses optical spectroscopy. A light-emitting tip non-invasively touches the lesion, receiving and analyzing data from below the skin at cellular and subcellular levels. The technology could help general practitioners better spot lesions that are potential problems before forwarding their patients to a dermatologist for further evaluation.

Research involving 57 general practitio…