Medical technology company PreciPoint today announced the launch of its iO:M8 live digital microscope. The microscope is an innovative solution for digitizing intraoperative examinations in cancer surgery. The device recently received certification as a CE-IVD product. This first product certification under the new IVDR regulation is an important milestone in PreciPoint’s corporate development.
PreciPoint is a young medical technology company producing solutions for the digitization of microscopy and laboratory processes for applications in medicine, research and education. In the development of its products, the company already collaborates with many renowned pathologists in Germany. On the one hand, many government-funded projects are advancing promising approaches in the therapy of numerous cancers, and on the other hand, the company is developing the devices that make these research results visible and simplify laboratory processes. “Where you live should not determine whether you live. The possibilities of digital pathology enable better patient care, and our products facilitate access to digital pathology,” explained Dominik Gerber, CEO of PreciPoint GmbH.
The company’s latest development, the iO:M8, offers a distinctive solution for digitizing intraoperative cancer exams. During these examinations, pathologists determine during surgery whether tumor tissue has been completely removed from the patient’s body and whether the margins of the operated site are free of cancer cells. Traditionally, these examinations are performed at a specific location and time using traditional light microscopy. However, the iO:M8 was developed specifically for this application and allows tissue removed during surgery to be cryostatically frozen in a frozen sectioning process, sectioned and mounted on glass slides. The iO:M8 can accommodate up to four slides simultaneously. It provides high-resolution images of the samples in real time while being easy to use. “In view of the increasing shortage of pathologists coupled with the rising number of cancer cases in Germany, Europe and worldwide, solutions like PreciPoint´s are indispensable,” commented Nicolas Weiss, who heads the company together with Dominik Gerber. The iO:M8 is a medical device used in medical therapy. Therefore, the basic principles of safety and performance must be demonstrated for use. Only the CE-IVD marking provides this security.
“We are pleased that our iO:M8 live microscope has passed all the required tests and regulations. This ensures that it meets the highest quality and reliability standards as an IVD medical device. This microscope will help drive digitization in healthcare and we are excited about the impact it will have in the medical community,” said Gerber. Nicolas Weiss added, “CE-IVD certification is a testament to the hard work and dedication of our team, which has invested countless months to ensure this microscope meets the highest performance and safety standards. With this certification, our customers can be assured that they are getting a safe, reliable and effective tool for their diagnostic tasks. We are very excited to bring this cutting-edge technology to market and contribute to the advancement of medical technology and healthcare.”
bm|t Investee Partner PreciPoint, is a certified medical device company (ISO 13485) that develops customized solutions to bridge the gap between digital workflows and pathologists. The company develops and distributes fully motorized light microscopes and scanners worldwide with a passion for bringing the digitization of microscopy to pathology. PreciPoint’s products include the M8 microscope and scanner, the O8 oil microscope and scanner, and the FRITZ scanner. These products produce high-resolution digital images of specimens for review and interpretation by professionals. In addition to hardware products, the company also offers multi-purpose software applications and services, including MicroPoint, ViewPoint, PreciCloud, ScanPoint, and ConvertPoint, as well as other customized solutions for pathologists and medical professionals. The company has received numerous awards and recognitions, including Top Employer 2023 and Top100 Innovator 2022, and PreciPoint has also been named a Top Employer for Healthcare Startups.