MassDevice Archives - Page 132 of 587 - Medical Design Sourcing

Surgalign releases HOLO AI Insights for neurovascular research

Surgalign (Nasdaq:SRGA) announced today that it released its HOLO AI Insights for use in neurovascular research.

Deerfield, Illinois-based Surgalign initially launched HOLO AI Insights for spine imaging in March 2023. It enables customers, partners and clinical researchers to utilize the HOLO AI portfolio. The system features a secure, highly scalable cloud platform for the automated analysis of medical images.

HOLO AI utilizes convolutional neural network technology. It automatically segments medical images, measures anatomic structures, automates pedicle screw planning and performs other tasks.

The latest release brings HOLO AI to neurovascular research. The system can analyze large sets of cranial MRI images and automatically identify 16 different structures. It can also aggregate the data for the user into configurable graphical and file formats. Insights generated this way can provide multiple applications in population health, clinical research and…

Conformis stock rises on Street-beating Q1

Conformis (Nasdaq:CFMS) shares ticked up today on first-quarter results that came in ahead of the consensus forecast.

Shares of CFMS rose 5.6% at $1.41 per share in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 0.7%.

The Billerica, Massachusetts-based orthopedic device maker posted losses of $9.57 million. That amounts to $1.32 per share on sales of $12.84 million for the three months ended March 31, 2023. Its losses per share came in 7¢ ahead of Wall Street predictions. Sales topped analysts’ expectations of $12.57 million in revenue, too.

Conformis recorded nearly halved its losses from the same time last year on a sales decline of 17.45%.

The company attributed its product revenue slide to decliens in U.S. knee orders, according to a news release. This comes on the heels of a change in Conformis’ business model, as well as manufacturing…

FDA approves ophthalmic spray from Eyenovia

[Image courtesy of Eyenovia]Eyenovia (Nasdaq:EYEN) announced today that the FDA approved its Mydcombi treatment for use with the Optejet delivery device.

New York-based Eyenovia designed Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. It marks the first approved fixed-dose combination of tropicamide and phenylephrine in the U.S.

Eyenovia said it also represents the first product using Eyenovia’s proprietary Optejet device to receive any regulatory approval.

Get the full story at our sister site, Drug Delivery Business News.

Baxter to divest its BioPharma Solutions business for $4.25B

Baxter (NYSE: BAX) + continues to streamline, announcing today that it will sell its pharma and biotech contract manufacturing business.

The Deerfield, Illinois-based medtech company — maker of diagnostic, critical care, kidney care, nutrition, hospital and surgical products and services — will sell its BioPharma Solutions (BPS) business to private equity firms Advent International and Warburg Pincus. Baxter expects the $4.25 billion sale to close in the second half of 2023, pending customary regulatory approvals and closing conditions.

After taxes, Baxter will receive roughly $3.4 billion from the deal.

“Today represents an important step in Baxter’s ongoing transformation journey as we continue to execute against our strategic priorities, enhance our focus and create additional value for all our stakeholders,” Baxter CEO José (Joe) E. Almeida said in a news release.

“BPS has long been recognized worldw…

Invacare completes restructuring, emerges from Chapter 11

Invacare (NYSE:IVC) announced today that it successfully emerged from Chapter 11 bankruptcy at the end of last week.

Elyria, Ohio-based Invacare began financial restructuring activities that included filing for bankruptcy in February. This saw the company enter into a “Restructuring Support Agreement” (RSA). The RSA covers substantially all of its debt holders. That includes its term loan lender, all holders of convertible senior secured notes and holders of a majority of convertible senior unsecured notes.

The RSA included a reduction of Invacare’s funded debt by approximately $240 million. It also featured a backstop for a rights offering to holders of claims, providing Invacare with $60 million in equity capital.

To effectuate these transactions, Invacare and two U.S.-based subsidiaries commenced voluntary Chapter 11 cases. They did so in the U.S. Bankruptcy Court for the Southern District of Texas. The company said its other businesses “remain strong…

TransMedics proposes $300M offering

TransMedics (Nasdaq:TMDX) announced today that it intends to offer $300 million in convertible senior unsecured notes.

Andover, Massachusetts-based TransMedics’ offering remains subject to market and other conditions. The notes mature on June 1, 2028, unless earlier redeemed, repurchased or converted, according to a news release.

TransMedics expects to grant the initial purchasers an option to purchase up to an additional $45 million in notes. That option falls within a 13-day period beginning on and including the issuance date of the notes. The company intends to use a portion of its proceeds to pay the cost of certain capped call transactions.

With the remaining proceeds, TransMedics plans to expand its logistics network. This could come through potential partnerships or acquisitions. The company also intends to use proceeds for general corporate purposes.

Details of the Transmedics offering

The notes — senior, unsecured obligations of Tra…

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 …

Insulet restructures leadership team to drive growth

Left: outgoing chief commercial officer Bret Christensen. Right: New Chief Product & Customer Experience Officer (CPXO) Eric Benjamin. [Images from Insulet]Insulet (Nasdaq:PODD) announced today that it reshuffled its organizational structure to accelerate innovation and commercialization.

In connection with the reorganization, Bret Christensen, EVP and chief commercial officer, leaves the company today to pursue other opportunities. He agreed to offer consulting services during a transition period.

Jim Hollingshead, Insulet’s president and CEO, said Christensen “played an integral role” in Insulet’s commercial success during his six-year spell with the company. He most recently played his part in the commercial launch of the next-generation Omnipod 5 automated insulin delivery system.

“[Christensen] helped build a deep, talented commercial team that has contributed to our strong customer base growth, an exceptional customer exper…

Study supports feasibility of Know Labs non-invasive CGM

[Image from Know Labs]Know Labs (NYSE:KNW) today announced the results of a feasibility study comparing its glucose monitoring technology to the Dexcom G6 CGM.

The company titled its study “Technical Feasibility of a Novel Sensor for Non-Invasive Blood Glucose Monitoring Compared to Dexcom G6.” It’s presenting results today at the American Association of Clinical Endocrinology (AACE) Annual Meeting in Seattle.

Know Labs conducted a series of internal studies between December 2022 and February 2023. The company sought to validate the technical feasibility of its Bio-RFID sensor technology for quantifying blood glucose concentration (BGC). Its studies evaluated five healthy participants using the Dexcom G6 as a reference device.

Get the full story at our sister site, Drug Delivery Business News.

Nuro secures patent for helmet to detect neurological disease

The PAD wireless portable neurological helmet technology for the early detection and continuous monitoring of neurological diseases. [Image courtesy of Nuro]Nuro announced that it received a fourth patent for its PAD neurological helmet for detecting neurological diseases like Alzheimer’s.

Waterloo, Ontario, Canada–based Nuro designed PAD as a wireless, portable helmet. It detects and continuously monitors various neurological diseases and disorders.

The company says that the system differs from traditional fMRI and PET scanners, which require investments, dedicated space and personnel. This new device assists primary care physicians with an ultra-rapid scan of key regions of the brain. It receives assistance in the form of live analysis, classification and result sharing with AI deep learning algorithms.

Nuro aims for its technology to provide unprecedented neurological insights to assist the healthcare system. It hopes for PAD to become a source of …

iRhythm faces another subpoena from the DOJ

Wearable cardiac monitor developer iRhythm (Nasdaq: IRTC) + disclosed its third subpoena in more than two years from federal investigators.

The news raised some questions from analysts, who were otherwise positive about iRhythm’s first-quarter earnings report yesterday evening.

San Francisco–based iRhythm said that on April 4, it received a subpoena duces tecum from the U.S. Department of Justice Civil Division’s Consumer Protection Branch. Company officials told analysts that they were fully cooperating. They said it was too early to speculate on the nature or timing of the inquiry.

Analysts noted that Boston Scientific said in its most recent quarterly report that it received a subpoena from the DOJ on April 5 seeking documents and information relating to its ambulatory electrocardiography monitoring (AECG) business. Boston Scientific is also cooperating.

BTIG analysts stuck with their Buy r…

Owens & Minor stock soars on Q1 results as realignment continues

Owens & Minor (NYSE:OMI) shares got a boost today on first-quarter results that came in ahead of the consensus forecast.

Shares of OMI rose 40.9% at $19.09 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 0.3%.

The Richmond, Virginia-based company posted losses of $24.4 million in the quarter. That equals 32¢ per share on sales of $2.5 billion for the three months ended March 31, 2023.

Owens & Minor reported a massive bottom-line slide into the red from profits of $39.3 million this time last year. However, the company registered 4.8% sales growth.

Adjusted to exclude one-time items, earnings per share totaled 5¢. That topped Wall Street projections of losses per share of 9¢. Sales came in at more than double what the analysts expected.

Edward A. Pesicka, president & CEO of Owens & Minor, said the company generated e…