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Home » Topics » Medical devices and technologies » Software

Software
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FDA Not Approved stamp

FDA rejects Artrya’s 510(k) for its AI-enabled Salix coronary anatomy software

June 24, 2022
By Tamra Sami
The FDA has rejected Artrya Ltd.’s 510(k) application for its Salix coronary anatomy (SCA) software that analyzes heart computed tomography scans via artificial intelligence (AI) to better diagnose coronary artery disease. “The FDA has advised that the Artrya Salix product is not equivalent to the predicate device,” Artrya CEO John Barrington told BioWorld.
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Spine analysis software on desktop monitor

SMAIO obtains clearance for surgery planning software and patient-specific rods for arthrodesis

June 17, 2022
By Bernard Banga
Just three months after raising $10 million from its IPO on the Paris Euronext Growth market, SMAIO SA (Software Machines and Adaptive Implants in Orthopedics) obtained U.S. FDA 510(k) clearance for its Balance Analyzer 3D surgery planning software and for its patient-specific union rods. This spinal realignment planning software uses medical imaging of the patient’s spine in an upright static position.
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Concept of business partnership

Resmed to pay $1B for software provider Medifox Dan

June 16, 2022
By Meg Bryant
Resmed Inc. has entered into a definitive agreement to acquire Medifox Dan GmbH, a German developer of out-of-hospital software solutions for providers in major settings across the care continuum, from software and services investor Hg. The deal – valued at roughly $1 billion – is expected to close by the end of the year, which is the end of the second quarter of Resmed’s 2023 fiscal year.
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Rapid PE Triage & Notification product

FDA gives nod to two AI solutions to speed CVD diagnoses

May 24, 2022
By Annette Boyle
The transformation of cardiology continues with two U.S. FDA actions to promote the use of artificial intelligence (AI): a 510(k) clearance for Rapidai Inc.’s pulmonary embolism (PE) triage and notification product and breakthrough device designation for Anumana Inc.’s pulmonary hypertension (PH) early detection algorithm.
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Singapore

Singapore updates guidelines for software as medical devices to expand scope

May 20, 2022
By David Ho
Singapore’s Health Sciences Authority (HSA) recently updated its guidelines for software as medical devices (SaMDs) to broaden its scope on a number of related matters. The new guidelines were finalized after an industry input period when the HSA collected feedback until the middle of August 2021. It marks the second revision of HSA guidelines on SaMDs, the first revision was meted out in April 2020. 
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Digital spine concept art

Nanox unit wins FDA clearance for spine analysis device

May 6, 2022
By Gina Lee
Nano-x Imaging Ltd.’s (Nanox) subsidiary Nanox.AI has received the FDA’s 510(k) clearance for Healthost, an artificial intelligence (AI) software device providing qualitative and quantitative analysis of the spine from CT scans.
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FDA advises on intended use of software used for patients with intracranial occlusions

April 13, 2022
By Mark McCarty
Clinicians are still at liberty to use medical products outside the labeled indication for use, but the U.S. FDA believes radiologists may be unaware of the limitations of radiological computer-aided triage and notification (CADt) software for intracranial large-vessel occlusion (LVOs). The agency advised clinicians that these programs are not intended for use as a substitute for radiologist review of images, but instead should be used only to flag suspect images as part of an effort to triage these patients.
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Woman working at computer in laboratory

Clinisys purchases cloud-based laboratory system Apollolims

April 13, 2022
By Catherine Longworth
Diagnostic testing group Clinisys Inc. has acquired cloud-based laboratory operations software company Apollolims in an undisclosed deal. Headquartered in Chertsey, U.K., and Tucson, Ariz., Clinisys will expand its public health, toxicology, and molecular diagnostics offering through the acquisition. The deal builds on the company’s combination with Sunquest and Horizon announced in January.
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Vercise Neural Navigator with Stimview XT software on tablet

FDA approval stimulates Boston Scientific’s Neural Navigator

April 12, 2022
By Annette Boyle
Boston Scientific Corp.’s image-guided programming software, Vercise Neural Navigator with Stimview XT, got the green light from the FDA for use with the company’s deep brain stimulation (DBS) portfolio in patients with essential tremor or Parkinson’s disease. The software, developed in a collaboration with Brainlab AG, provides more sophisticated image-guided programming tools for personalization of the stimulation therapy, halving the time needed for adjustments and increasing precision.
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Cloud/cybersecurity illustration

FDA says PTC Axeda software vulnerabilities affect wide range of medical devices

March 10, 2022
By Mark McCarty
The U.S. FDA has issued an advisory regarding vulnerabilities identified in the Axeda line of remote access software published by PTC Inc., which may affect more than 100 products made by dozens of manufacturers. The vulnerability could allow a hacker to trigger changes in the operation of the affected devices, a massive risk to patients undergoing medical imaging and radiotherapy procedures. The FDA notice stated that the Axeda Agent and desktop server programs are the subject of a notice by the Cybersecurity & Infrastructure Security Agency (CISA), which characterizes the vulnerability as requiring only a low-complexity attack to exploit.
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